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The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuCath IV Catheter Device | Experimental | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal |
|
| Conventional IV Catheter Device | Active Comparator | Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuCath IV Catheter Device | Device | Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| First Attempt Success Rate With Peripheral IV Catheter Placement | The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement. | At catheter placement, an expected average of 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of IV Therapy | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days). | Study exit/At catheter removal (~ up to 7 days) |
| Complications of Peripheral IV Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Rowbottom, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Bette Idemoto, PhD, RN | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AccuCath IV Catheter Device | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
| FG001 | Conventional IV Catheter Device | Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AccuCath IV Catheter Device | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | First Attempt Success Rate With Peripheral IV Catheter Placement | The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement. | Posted | Number | 95% Confidence Interval | percentage of participants | At catheter placement, an expected average of 10 minutes |
|
During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AccuCath IV Catheter Device | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Gilbert | C. R. Bard | 407-489-0835 | gina.gilbert@crbard.com |
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|
| Conventional IV Catheter Device | Device | Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. |
|
|
Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days). |
| From during to post IV catheter placement up to study exit (~ up to 7 days) |
| Catheter Dwell Time | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days. | Study Exit/At catheter removal (~ up to 7 days) |
| Patient Satisfaction At Insertion | Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | At catheter insertion, initial 3-15 minutes after insertion procedure completed. |
| Clinician Satisfaction | Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | At completion of study after all patients have been enrolled (approximately 6 months from study initiation) |
| Adverse Events | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time. | During and post IV catheter placement until study exit (maximum of 6 months). |
| Patient Satisfaction Comfort Comparison | Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure. |
| Patient Satisfaction With Overall IV Performance | Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | At IV removal (usually after 1-7 days of IV dwell time) |
| BG001 |
| Conventional IV Catheter Device |
Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. |
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|
|
| Secondary | Completion of IV Therapy | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days). | Posted | Number | 95% Confidence Interval | percentage of participants | Study exit/At catheter removal (~ up to 7 days) |
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| Secondary | Complications of Peripheral IV Therapy | Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days). | Posted | Number | 95% Confidence Interval | percentage of participants | From during to post IV catheter placement up to study exit (~ up to 7 days) |
|
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| Secondary | Catheter Dwell Time | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days. | Posted | Mean | Standard Deviation | hours | Study Exit/At catheter removal (~ up to 7 days) |
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| Secondary | Patient Satisfaction At Insertion | Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | Posted | Mean | Standard Deviation | units on a scale | At catheter insertion, initial 3-15 minutes after insertion procedure completed. |
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| Secondary | Clinician Satisfaction | Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | Posted | Mean | Full Range | units on a scale | At completion of study after all patients have been enrolled (approximately 6 months from study initiation) |
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| Secondary | Adverse Events | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time. | Posted | Number | percentage of participants | During and post IV catheter placement until study exit (maximum of 6 months). |
|
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| Secondary | Patient Satisfaction Comfort Comparison | Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | Posted | Mean | Standard Deviation | units on a scale | Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure. |
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| Secondary | Patient Satisfaction With Overall IV Performance | Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. | Posted | Mean | Standard Deviation | units on a scale | At IV removal (usually after 1-7 days of IV dwell time) |
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| 0 |
| 123 |
| 10 |
| 123 |
| EG001 | Conventional IV Catheter Device | Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. | 0 | 125 | 65 | 125 |
| Infiltration | Vascular disorders | Systematic Assessment |
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| Dislodgement | Vascular disorders | Systematic Assessment |
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| Occlusion | Vascular disorders | Systematic Assessment |
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| Leaking | Vascular disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Leaking |
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| Occlusion |
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| Dislodgement |
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