A New Technique for Determining Limb Occlusion Pressure

November 2, 2020 updated by: James A. McEwen, University of British Columbia
This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler ultrasound technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). However, LOP is not yet routinely measured in all patients due to limitations of current techniques. This study evaluates a novel technique for measuring the LOP through the tourniquet cuff that overcomes many limitations of current LOP measurement techniques.

The goal of the study is to determine if the LOP measured by the new technique is statistically or clinically different from the LOP measured by a gold standard Doppler ultrasound technique in adult and pediatric patients

Study Type

Interventional

Enrollment (Actual)

203

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Complex Joint Clinic, Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 3C6
        • Cambie Surgery Centre
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Foot and Ankle Clinic, St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • BC Children's and Women's 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

5 months to 96 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for a visit to one of four surgical clinics in Vancouver, Canada
  • Agreed to participate in the study and provide informed consent

Exclusion Criteria:

  • Unable to give informed consent on their own behalf or by a legal guardian
  • Lack of parental agreement in the case of consent from a legally competent minor
  • Standard contraindications to tourniquet use
  • Vascular disease or circulation problems in the extremities
  • History or indication of deep vein thrombosis

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOP Measurement
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument and the gold-standard technique with the handheld Doppler ultrasound.
Device: Personalized Tourniquet Instrument
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.
Device: Handheld Doppler ultrasound
Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
Time Frame: at time of measurement
at time of measurement

Secondary Outcome Measures

Outcome Measure
Time Frame
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique
Time Frame: at time of measurement
at time of measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: James A McEwen, PhD, University of British Columbia

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.

General Publications

Helpful Links

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, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H14-02048

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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