- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276171
Ultrasound-image Guided Versus Doppler Guided Versus Palpation Technique for Arterial Cannulation in Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radial artery cannulation is a common invasive procedure in the operating room, intensive care unit and emergency department. It allows continuous hemodynamic monitoring and repeated arterial blood sampling. Although severe complications are rare, successful radial artery cannulation can be technically challenging, particularly in hypotensive patients and those with vascular disease. Multiple unsuccessful attempts at arterial cannulation increase patient discomfort, delay timely care and may also contribute to adverse events such as arterial spasm or local hematoma.
The radial artery is traditionally located by palpation. A number of techniques to aid radial artery localization have been described. Doppler-assisted radial arterial cannulation was first described in 1976. Several case reports suggest that Doppler can be helpful in patients with difficult arterial access. More recently, ultrasound-guided radial artery cannulation has been described. In a recent meta-analysis of four randomized controlled trials, ultrasound increased the rate of cannulation on the first attempt by 71% compared with palpation. However, two of the studies were of children and all four were small, with 30-152 participants (311 in total), making the generalizability of these results to adult patients uncertain. Furthermore, variation in the training and experience of the operators was evident within one of the studies.
Accordingly, the aim of this study is to compare three different radial arterial cannulation techniques in adult surgical patients when performed by anesthesia residents: Doppler; palpation; and ultrasound. We think that ultrasound would have a higher rate of cannulation on the first attempt compared with other techniques.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Main OR patients at UIHC who require arterial catheter placement for surgery
Exclusion Criteria:
- The patients who will be excluded from the study include those who have had arterial cannulation in the previous month, infections at site of insertion, and AV shunts in upper extremity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasound
Participants will place arterial line using ultrasound technique
|
Participants will place arterial line using ultrasound technique
|
|
Active Comparator: Doppler
Participants will place arterial line using doppler technique
|
Participants will place arterial line using doppler technique
|
|
Active Comparator: Palpation
Participants will place arterial line using palpation technique
|
Participants will place arterial line using Palpation technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First Attempt Success Rate With 3 Different Technique
Time Frame: 5 minutes
|
The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees.
Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to Successful Cannulation
Time Frame: 5 minutes
|
5 minutes
|
|
Total Success Rate
Time Frame: 5 min
|
5 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenichi Ueda, MD, University of Iowa
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 201001776
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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