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A New Technique for Determining Limb Occlusion Pressure

NCT ID: NCT02620722

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Tourniquet Safety and Effectiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Personalized Tourniquet Instrument

Intervention Type DEVICE

Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.

Handheld Doppler ultrasound

Intervention Type DEVICE

Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

Interventions

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Personalized Tourniquet Instrument

Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.

Intervention Type DEVICE

Handheld Doppler ultrasound

Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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James A. McEwen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James A McEwen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Complex Joint Clinic, Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Cambie Surgery Centre

Vancouver, British Columbia, Canada

Site Status

Foot and Ankle Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

BC Children's and Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.

Reference Type BACKGROUND
PMID: 19952261 (View on PubMed)

Related Links

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http://tourniquets.org/index.php

Educational website about tourniquets

Other Identifiers

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H14-02048

Identifier Type: -

Identifier Source: org_study_id