- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02668471
U/S Guided vs. Traditional Palpation for Radial Artery Cannulation
April 25, 2017 updated by: Nattachai Anantasit, Ramathibodi Hospital
Ultrasound-guided Compared With Traditional Palpation Radial Artery Cannulation in Critically Ill Children
The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling.
However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients.
There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication.
Recently no setting published in pediatric intensive care unit.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Department of Pediatric,Ramathibodi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit
Exclusion Criteria:
- Wound at area of cannulation
- Can not palpate or weak radial artery pulse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultrasound guided
Radial artery catheters will be placed with the assistance of bedside ultrasound.
|
ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation
|
Active Comparator: traditional method
Radial artery catheters will be placed by the palpation technique only.
|
Radial artery catheters will be placed by the palpation technique only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
first attempt success rate of radial artery catheter insertion
Time Frame: 5 minute
|
5 minute
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to success of radial artery catheter insertion
Time Frame: 15 minute
|
15 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
August 30, 2016
Study Completion (Actual)
August 30, 2016
Study Registration Dates
First Submitted
January 22, 2016
First Submitted That Met QC Criteria
January 26, 2016
First Posted (Estimate)
January 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-09-58-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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