- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02092415
Assessment of Limb Perfusion During Junctional Tourniquet
May 8, 2015 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University
The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT).
Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU
-
-
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
19 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subject
- Age 19-50
Exclusion Criteria:
- Peripheral artery disease
- Known heart failure
- Right to left shunt
- Pregnancy
- Presence of femoral artery aneurysm
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal subjects
Normal subjects, all of whom undergo brief application of junctional tourniquet
|
All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Perfusion
Time Frame: baseline and 1 min post occlusion
|
Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
|
baseline and 1 min post occlusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan R Lindner, MD, Oregon Health and Science University
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
September 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
January 6, 2014
First Submitted That Met QC Criteria
March 18, 2014
First Posted (Estimate)
March 20, 2014
Study Record Updates
Last Update Posted (Estimate)
May 29, 2015
Last Update Submitted That Met QC Criteria
May 8, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Junctional Tourniquet
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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