Trial Outcomes & Findings for Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters (NCT NCT01663779)

NCT ID: NCT01663779

Last Updated: 2015-08-31

Results Overview

first pass success when attempting arterial catheterization of the artery

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Immediate, upon study entry

Results posted on

2015-08-31

Participant Flow

Participant milestones

Participant milestones
Measure
Ultrasound Radial Artery Catheter
Ultrasound guided radial artery catheterization. Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound.
Palpation Based Artery Catheterization
Blind insertion of radial artery catheterization Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only.
Overall Study
STARTED
27
23
Overall Study
COMPLETED
27
23
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ultrasound Radial Artery Catheter
n=27 Participants
Ultrasound guided radial artery catheterization. Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound.
Palpation Based Artery Catheterization
n=23 Participants
Blind insertion of radial artery catheterization Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only.
Total
n=50 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
22 Participants
n=5 Participants
18 Participants
n=7 Participants
40 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex/Gender, Customized
unknown
27 participants
n=5 Participants
23 participants
n=7 Participants
50 participants
n=5 Participants
Region of Enrollment
United States
27 participants
n=5 Participants
23 participants
n=7 Participants
50 participants
n=5 Participants

PRIMARY outcome

Timeframe: Immediate, upon study entry

first pass success when attempting arterial catheterization of the artery

Outcome measures

Outcome measures
Measure
Ultrasound
n=27 Participants
ultrasound atery
Palpation
n=23 Participants
palpation artery
First Pass Success When Attempting Arterial Catheterization.
22 participants
10 participants

Adverse Events

Ultrasound

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Palpation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ultrasound
n=27 participants at risk
ultrasound artery
Palpation
n=23 participants at risk
palpation artery
Skin and subcutaneous tissue disorders
subcutaneous hematoma <1cm
3.7%
1/27 • Number of events 1 • entire study
0.00%
0/23 • entire study

Additional Information

Kevin M. Schuster

Yale School of Medicine

Phone: 203-785-2572

Results disclosure agreements

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