Trial Outcomes & Findings for AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use (NCT NCT01943474)
NCT ID: NCT01943474
Last Updated: 2017-03-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
At catheter placement, an expected average of 10 minutes
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
125
|
|
Overall Study
COMPLETED
|
123
|
125
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
Baseline characteristics by cohort
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 15.5 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 14.5 • n=107 Participants
|
62.5 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=99 Participants
|
125 participants
n=107 Participants
|
248 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At catheter placement, an expected average of 10 minutesThe 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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
First Attempt Success Rate With Peripheral IV Catheter Placement
|
89 percentage of participants
Interval 82.8 to 93.7
|
47 percentage of participants
Interval 38.7 to 55.9
|
SECONDARY outcome
Timeframe: Study exit/At catheter removal (~ up to 7 days)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).
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Completion of IV Therapy
|
89.4 percentage of participants
Interval 82.8 to 93.7
|
34.4 percentage of participants
Interval 26.6 to 43.1
|
SECONDARY outcome
Timeframe: From during to post IV catheter placement up to study exit (~ up to 7 days)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).
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Complications of Peripheral IV Therapy
|
8 percentage of participants
Interval 4.5 to 14.3
|
52 percentage of participants
Interval 43.3 to 60.6
|
SECONDARY outcome
Timeframe: Study Exit/At catheter removal (~ up to 7 days)Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) \~ up to 7 days.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Catheter Dwell Time
|
105 hours
Standard Deviation 61
|
35 hours
Standard Deviation 25
|
SECONDARY outcome
Timeframe: At catheter insertion, initial 3-15 minutes after insertion procedure completed.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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Patient Satisfaction At Insertion
|
4.6 units on a scale
Standard Deviation 0.69
|
3.0 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=18 Participants
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.
|
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.
|
|---|---|---|
|
Clinician Satisfaction
|
4 units on a scale
Interval 1.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: During and post IV catheter placement until study exit (maximum of 6 months).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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Adverse Events
Infiltration
|
2.4 percentage of participants
|
26.4 percentage of participants
|
|
Adverse Events
Phlebitis
|
0.8 percentage of participants
|
8.8 percentage of participants
|
|
Adverse Events
Leaking
|
0.8 percentage of participants
|
5.6 percentage of participants
|
|
Adverse Events
Occlusion
|
1.6 percentage of participants
|
5.6 percentage of participants
|
|
Adverse Events
Dislodgement
|
2.4 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Patient Satisfaction Comfort Comparison
|
4.2 units on a scale
Standard Deviation 1.02
|
2.86 units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: At IV removal (usually after 1-7 days of IV dwell time)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.
Outcome measures
| Measure |
AccuCath IV Catheter Device
n=123 Participants
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.
|
Conventional IV Catheter Device
n=125 Participants
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.
|
|---|---|---|
|
Patient Satisfaction With Overall IV Performance
|
4.84 units on a scale
Standard Deviation 0.41
|
2.84 units on a scale
Standard Deviation 1.01
|
Adverse Events
AccuCath IV Catheter Device
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Conventional IV Catheter Device
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AccuCath IV Catheter Device
n=123 participants at risk
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.
|
Conventional IV Catheter Device
n=125 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Phlebitis
|
0.81%
1/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
8.8%
11/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
Vascular disorders
Infiltration
|
2.4%
3/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
26.4%
33/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
Vascular disorders
Dislodgement
|
2.4%
3/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
4.8%
6/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
Vascular disorders
Occlusion
|
1.6%
2/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
5.6%
7/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
Vascular disorders
Leaking
|
0.81%
1/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
5.6%
7/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
Infections and infestations
Infection
|
0.00%
0/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
0.80%
1/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
|
General disorders
Pain
|
0.00%
0/123 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
1.6%
2/125 • During study enrollment from April 2013 - June 2013
Adverse events are the anticipated complications of IV therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60