Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gus Gear Inc | UNKNOWN |
| Society of Pediatric Nurses | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data.
Scheme and Outcomes: Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study.
Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey.
Note: Vest is a Class I Exempt FDA-registered device.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No groups | Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gus gear protective wearable device | Device | Gus gear protective wearable device for central line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device | No. of participants who were interviewed i.e. parents (of children using Gus gear vest) on device. Semi-structured interview guide was used to collect interview from parents. Eligible parents were parents of children between 0-12 years of age using the vest, and Parents should be able to speak English/Spanish. Interviews being qualitative in nature, the criteria to assess feasibility from parents using the vest will be done using transcription and inductive content analysis to find codes and themes from the data provided by the parents during the interview. | Two weeks from recruitment, plus or minus seven days. |
| Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device | Every month complete 30-day satisfaction survey for a total of three data collection period | Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data. |
| Satisfaction Survey From Nurses | Satisfaction survey from nurses of Children using the Gus gear vest device | Anytime during the study period up to nine months. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.
Not provided
Not provided
Patients with CVCs ages 0 to 12 years of age
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Leal, BSN, RN, CPN | Children's Health UTSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health | Dallas | Texas | 75235 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Groups | As per protocol, there were 30 participants who were enrolled (they were all eligible and consented to the study). During the course of data collection, 6 out of 30 were unenrolled due to failed for follow-up/did not complete the data collection process. Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Gus gear protective wearable device: Gus gear protective wearable device for central line. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Groups | Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Gus gear protective wearable device: Gus gear protective wearable device for central line. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device | No. of participants who were interviewed i.e. parents (of children using Gus gear vest) on device. Semi-structured interview guide was used to collect interview from parents. Eligible parents were parents of children between 0-12 years of age using the vest, and Parents should be able to speak English/Spanish. Interviews being qualitative in nature, the criteria to assess feasibility from parents using the vest will be done using transcription and inductive content analysis to find codes and themes from the data provided by the parents during the interview. | 30 is the enrolled number for quantitative piece of the study. Being mixed methods in nature in design, this study also has qualitative part. Upon interviewing 12 parents, thematic saturation was achieved to conclude data collection for the qualitative part of the study. | Posted | Number | Interviews | Two weeks from recruitment, plus or minus seven days. | interviews | interviews |
|
Through study completion, an average of 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Groups | Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Gus gear protective wearable device: Gus gear protective wearable device for central line. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Leal | Children's Medical Center | 2144560276 | Maria.leal@childrens.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2022 | Oct 16, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | 6 out of 30 were unenrolled | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 6 out of 30 were unenrolled | Count of Participants | Participants |
|
| No Groups |
Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. |
|
|
| Primary | Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device | Every month complete 30-day satisfaction survey for a total of three data collection period | Not Posted | Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data. | Participants |
| Primary | Satisfaction Survey From Nurses | Satisfaction survey from nurses of Children using the Gus gear vest device | Not Posted | Anytime during the study period up to nine months. | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
Not provided
Not provided