- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405428
Ultrasonography For Radial Artery Diameter Measurement And Its Correlation With Allen Test
March 12, 2018 updated by: Guniz M.Koksal, Istanbul University
Radial Artery Diameter Measurement By Ultrasonography For Determination Of Proper Cannula Size And Investigation Of Correlation Between Allen Test And Doppler Ultrasonography
In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography.
The correlation of Allen test with doppler ultrasonography will also be evaluated.
Study Overview
Status
Unknown
Conditions
Detailed Description
Arterial catheterization for continuous hemodynamic monitoring or frequent blood sampling is a common procedure in anesthesia and critical care setting.
The most commonly used site for arterial catheterization is the radial artery because of its superficial course, alternate blood supply to hand via ulnar artery and a low rate of complications.
Allen test is a simple, but not reliable, method for assessing the safety of radial artery catheterization.
Intraarterial catheterization has some complications such as hematoma, vasospasm, arterial thrombosis, necrosis of skin overlying.
Using larger size cannula from radial artery diameter, increase rate of complications.
The purpose of this study is to investigate the corelation of radial artery diameter with sex, age, height, weight and body mass index for determination of proper cannula size and investigation of correlation between Allen test and doppler ultrasonography.
Study Type
Interventional
Enrollment (Anticipated)
500
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
-
-
-
Istanbul, Turkey
- Recruiting
- Istanbul University Cerrahpasa Medical Faculty
-
Contact:
- Ayşe Sıla Akkuş
- Phone Number: 00905553044975
- Email: aysesilaakkus@hotmail.com
-
-
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients will be operated under general anesthesia
- patients were American Society of Anesthesiology (ASA) physical status I or II
Exclusion Criteria:
- ASA III, IV, V
- History of coroner artery disease
- History of peripheral artery disease,
- History of diabetes mellitus,
- History of hypertension
- Hemodynamic instability
- Hypovolemia
- History of Reynaud phenomenon
- History of hand or arm trauma
- previous catheterization
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: All patients
|
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched.
The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery.
Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results.
The time required for palmar capillary refill is noted.
An abnormal Allen test result was defined as a recovery time of more than 10 seconds.
Ultrasonography measurements will be performed with a linear probe before and after induction.
The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair.
The wrist joint of patient will be extended to 30 degrees with a wrist pad.
The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned.
The diameter of the radial artery will be measured and recorded.
Ultrasonography measurements will be performed with a linear probe before and after induction.
The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair.
The wrist joint of patient will be extended to 30 degrees with a wrist pad.
The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned.
The blood fow of ulnar artery will be measured and recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of the radial artery diameter according to sex, age, height, weight and body mass index
Time Frame: 5 minutes prior to anesthesia induction
|
Ultrasonography measurements will be performed with a linear probe.
The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair.
The wrist joint of patient will be extended to 30 degree with a wrist pad.
The Ultrasonography probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned.
The diameter of the radial artery will be measured and recorded.
|
5 minutes prior to anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between Allen test and doppler ultrasonography.
Time Frame: 5 minutes prior to anesthesia induction
|
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several seconds until the palmar skin is blanched.
The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery.
The time required for palmar capillary refill is noted.
An abnormal Allen test result was defined as a recovery time of more than 10 seconds.
Ultrasonography measurements will be performed with a linear probe.
The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair.
The wrist joint of patient will be extended to 30 degree with a wrist pad.
The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar artery will be scanned.
The blood fow of ulnar artery will be measured and recorded.
|
5 minutes prior to anesthesia induction
|
change of the radial artery diameter according to sex, age, height, weight and body mass index after the induction
Time Frame: 5 minutes following to anesthesia induction
|
Ultrasonography measurements will be performed with a linear probe.
The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair.
The wrist joint of patient will be extended to 30 degree with a wrist pad.
The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial arter will be scanned.
The diameter of the radial artery will be measured and recorded.
|
5 minutes following to anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Güniz Meyancı Köksal, Prof., Istanbul University Cerrahpasa Medical Faculty
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)
February 1, 2018
Primary Completion (Anticipated)
April 1, 2018
Study Completion (Anticipated)
April 30, 2018
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 19, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 419999
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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