Trial Outcomes & Findings for Ultrasound-Guided Peripheral Venous Access Using AccuCath (NCT NCT02469038)

NCT ID: NCT02469038

Last Updated: 2020-12-30

Results Overview

Rate of success of first attempt for IV access

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: During length of stay in emergency room up to 24 hours
• Results posted on: 2020-12-30

Participant Flow

Participant milestones

Measure	AccuCath Catheter We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Overall Study STARTED	26	24
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	AccuCath Catheter We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Overall Study Physician Decision	4	5

Baseline Characteristics

Ultrasound-Guided Peripheral Venous Access Using AccuCath

Baseline characteristics by cohort

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 19.4 • n=5 Participants	51.6 years STANDARD_DEVIATION 17.5 • n=7 Participants	46.9 years STANDARD_DEVIATION 18.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: During length of stay in emergency room up to 24 hours

Rate of success of first attempt for IV access

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
First Attempt Success Rate	17 Participants	11 Participants

SECONDARY outcome

Timeframe: During length of stay in emergency room up to 24 hours

Procedure time from the point of first percutaneous puncture to successful cannulation

Outcome measures

Measure	AccuCath Catheter n=10 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=8 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
IV Procedure Time	294.5 seconds Standard Deviation 217.6	740.3 seconds Standard Deviation 1222.6

OTHER_PRE_SPECIFIED outcome

Timeframe: During length of stay in emergency room up to 24 hours

Total number of percutaneous punctures required for successful cannulation

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Total Number of Percutaneous Punctures	1.4 punctures Standard Deviation 0.9	1.7 punctures Standard Deviation 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: During length of stay in emergency room up to 24 hours

Total number of IV catheters required for successful cannulation

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Total Number of IV Catheters	1.1 total number of catheters Standard Deviation 0.3	1.6 total number of catheters Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: During length of stay in emergency room up to 24 hours

Patient satisfaction data with each catheter system on a 5-point Likert scale minimum value=1, maximum value=5, higher scores are a better outcome

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Patient Satisfaction Data	4.2 units on a scale Standard Deviation 1.2	3.7 units on a scale Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: During length of stay in emergency room up to 24 hours

Provider satisfaction data with each catheter system on a 5-point Likert scale minimum value=1, maximum value=5, higher scores are a better outcome

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Provider Satisfaction Data	4.1 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: During length of stay in emergency room up to 24 hours

medical history

Outcome measures

Measure	AccuCath Catheter n=22 Participants We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group. AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.	Control n=19 Participants We will use ultrasound-guided conventional IV for patients in the control group. Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Clinical and Demographic Information Hypertension	5 participants	16 participants
Clinical and Demographic Information Type 1 Diabetes	0 participants	2 participants
Clinical and Demographic Information Type 2 Diabetes	4 participants	9 participants
Clinical and Demographic Information COPD	1 participants	2 participants
Clinical and Demographic Information Smoker	2 participants	3 participants
Clinical and Demographic Information Dialysis	4 participants	3 participants
Clinical and Demographic Information History of Difficult Needle Stick	10 participants	12 participants
Clinical and Demographic Information Sickle Cell Disease	7 participants	2 participants
Clinical and Demographic Information Congestive Heart Failure	3 participants	5 participants

Adverse Events

AccuCath Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melanie Norstrom

University of Chicago

Phone: 773-702-1991

Email: mnorstrom@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place