A New Technique for Determining Limb Occlusion Pressure

Not Applicable

Completed

• Conditions: Tourniquet Safety and Effectiveness
• Interventions: Device: Personalized Tourniquet Instrument; Device: Handheld Doppler ultrasound

• Registration Number: NCT02620722
• Lead Sponsor: University of British Columbia

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LOP Measurement	Personalized Tourniquet Instrument	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.
LOP Measurement	Handheld Doppler ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique	at time of measurement

Secondary Outcome Measures

Name	Time	Method
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique	at time of measurement

Trial Locations

Locations (4)

Cambie Surgery Centre; 🇨🇦 Vancouver, British Columbia, Canada

Foot and Ankle Clinic, St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

BC Children's and Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Complex Joint Clinic, Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada