Overview

This trial is active, not recruiting.

Condition tourniquet safety and effectiveness
Treatments personalized tourniquet instrument, standard tourniquet instrument, handheld doppler ultrasound
Sponsor University of British Columbia
Start date September 2014
End date September 2017
Trial size 143 participants
Trial identifier NCT02620722, H14-02048

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, an existing distal sensor-based technique, and a gold standard Doppler ultrasound technique.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument, the existing distal-sensor based technique with the standard tourniquet instrument, and the gold-standard technique with the handheld Doppler ultrasound.
personalized tourniquet instrument
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.
standard tourniquet instrument
Measure the limb occlusion pressure in each patient using the existing distal sensor-based technique with the standard tourniquet instrument.
handheld doppler ultrasound
Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 16 years up to 100 years old.

Inclusion Criteria: - Scheduled for a visit to one of three 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 - Standard contraindications to tourniquet use - Vascular disease or circulation problems in the extremities - History or indication of deep vein thrombosis

Additional Information

Official title A New Technique for Determining Limb Occlusion Pressure
Principal investigator James A McEwen, PhD
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 an existing distal sensor-based technique and a gold standard Doppler ultrasound technique.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.