| Primary | Primary Outcome - Line Breaks | Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line. | | Posted | | Mean | Standard Deviation | Line breaks/month | | For a maximum of 1 year from enrollment | | | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing | Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000.05± .09
- OG001.05± .07
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.) | t-test, 1 sided | | .029 | | | | | | | | | | | | | | Other | | |
|
| Primary | Primary Outcome - Line Replacement | Number of line replacements in which a line was removed from the patient and a new line was placed. | | Posted | | Mean | Standard Deviation | Events per month | | For a maximum of 1 year from enrollment | | | | ID | Title | Description |
|---|
| OG000 | Device | After randomization and device securementall families filled out a baseline demographics form and a baseline QOL survey. Patients were then followed for 12 months from initial enrollment. At subsequent clinic visits patients and families filled out follow-up surveys detailing potential line related complications. They were also given the same QOL survey that they filled out at the time of initial enrollment. These follow-up surveys were administered between 3-6 times throughout the year. Subjects' charts were routinely reviewed over the study, monitoring for ER visits, hospital admissions and line related complications. | | OG001 | Traditional Securement Dressing | After randomization all families filled out a baseline demographics form and a baseline QOL survey. Patients were then followed for 12 months from initial enrollment. At subsequent clinic visits patients and families filled out follow-up surveys detailing potential line related complications. They were also given the same QOL survey that they filled out at the time of initial enrollment. These follow-up surveys were administered between 3-6 times throughout the year. Subjects' charts were routinely reviewed over the study, monitoring for ER visits, hospital admissions and line related complications. |
|
| Primary | Primary Outcome - Line Infections | Number of line infections defined as a positive blood culture drawn from a central line. | | Posted | | Mean | Standard Deviation | Infections/Month | | For a maximum of 1 year from enrollment | | | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing | Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line. |
| |
| Secondary | How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. Traditional Securement Dressing: All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement. |
|
| Secondary | How Has the Vest or Dressing Affected Your Child's Ability to be Active? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
|
| Secondary | How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better and 6 being non applicable. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
|
| Secondary | Have You Been Worried About the Safety of Your Child's Central Line? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has Your Child Been Able to Take a Long Walk or Play? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has Your Child Been Able to Take a Short Walk Outside of the House? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Are You Worried About Your Child's Current Health? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has Your Child Needed to Stay in Bed or a Chair During the Day? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
|
| Secondary | Is Your Child Able to Socialize? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Is Your Child Able to do Sports/Exercise? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Is Your Child Able to Attend School/Pre-school? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Does Having a Central Line Affect His/Her Participation in School? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Does Having a Central Line Affect His or Her Learning at School? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Is Your Child Able to Take Part in Hobbies or Leisure Activities? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Is Your Child Able to Feel Independent? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has the Vest or Dressing Been Easy to Use? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has the Vest or Dressing Been Comfortable to Wear? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
|
| Secondary | Has the Vest or Dressing Kept You Child's Central Line Safe? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
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| Secondary | Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
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| Secondary | Has the Vest or Dressing Enabled Your Child to be More Active? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
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| Secondary | Has the Presence of a Central Line Affected Their Body Image? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
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| Secondary | How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-10 with 1 being very bad, 10 being very good. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
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| Secondary | How Would You Rate Your Child's Ability to Cope With Day to Day Activities? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
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| Secondary | How Has Your Child's Quality-of-life Been Affected by Vest or Dressing? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 | Traditional Securement Dressing |
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| Secondary | How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness? | Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question. | | Posted | | Mean | Standard Deviation | score on a scale | | Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months. | Total Responses | Total Responses | | ID | Title | Description |
|---|
| OG000 | Device | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | | OG001 |
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