- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217019
Guidewire-assisted Radial A-line in Neonate and Infant
April 5, 2019 updated by: Jin-Tae Kim, Seoul National University Hospital
Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted
In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.
The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
-
Seoul, Korea, Republic of
- Jin-Tae Kim
-
-
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
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)
Exclusion Criteria:
- Skin lesion, infection, hematoma, recent cannulation at cannulation site
- Unstable radial pulse (d/t unstable vital sign, or arrhythmias)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guidewire
|
catheter insertion with guidewire-assist(catheter over guidewire)
|
Active Comparator: Direct
|
catheter insertion without guidewire assist(catheter over needle)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate at 1st attempt (%)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
successful catheter insertion after obtaining 1st blood flush in angiocatheter.
|
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total elapsed time (seconds)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
total time for successful cannulation.
|
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
number of total cannulation attempts (number)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
number of total attempts until successful cannulation.
(1 attempt = 1 blood flush)
|
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
number of total catheter used (number)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
number of total catheter used until successful cannulation.
|
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
|
malfunction of arterial line
Time Frame: from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
|
pressure monitoring, blood sampling
|
from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
|
complications
Time Frame: from the arterial cannulation until the end of anesthesia (up to 1 day)
|
hematoma, ischemia
|
from the arterial cannulation until the end of anesthesia (up to 1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jin-Tae Kim, MD, PhD, Professor
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 (Actual)
August 7, 2017
Primary Completion (Actual)
July 4, 2018
Study Completion (Actual)
July 4, 2018
Study Registration Dates
First Submitted
July 10, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (Actual)
July 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1706-086-859
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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