Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Limb Perfusion During Junctional Tourniquet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092415
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Lindner, MD, Oregon Health and Science University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bleeding Device: Application of a Junctional Tourniquet Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Limb Perfusion During Junctional Tourniquet
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Normal subjects
Normal subjects, all of whom undergo brief application of junctional tourniquet
 Device: Application of a Junctional Tourniquet
All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092415


Locations
Layout table for location information
United States, Oregon
OHSU
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Jonathan R Lindner, MD Oregon Health and Science University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jonathan R. Lindner, MD, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02092415    
Other Study ID Numbers: Junctional Tourniquet
First Posted: March 20, 2014    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Jonathan R. Lindner, MD, Oregon Health and Science University:
Tourniquet
Muscle perfusion
Contrast ultrasound