A New Technique for Determining Limb Occlusion Pressure

University of British Columbia

Status: Completed

Conditions: Tourniquet Safety and Effectiveness

Treatments: Device: Personalized Tourniquet Instrument; Device: Handheld Doppler ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02620722

H14-02048

Details and patient eligibility

About

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.

Full 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

Enrollment: 203 patients

Sex: All

Ages: 3 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

203 participants in 1 patient group

LOP Measurement

Experimental group

Description:

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.

Treatment:

Device: Handheld Doppler ultrasound

Device: Personalized Tourniquet Instrument