A New Technique for Determining Limb Occlusion Pressure

Study Overview
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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

Official Title
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A New Technique for Determining Limb Occlusion Pressure

Conditions
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Tourniquet Safety and Effectiveness

Intervention / Treatment
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* Device: Personalized Tourniquet Instrument
* Device: Handheld Doppler ultrasound


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOP Measurement<br>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<br>* Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.<br>Device: Handheld Doppler ultrasound<br>* Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tourniquet, safety, personalized, surgery