A New Technique for Determining Limb Occlusion Pressure

Tourniquet Safety and Effectiveness Clinical Trial

Official title:

A New Technique for Determining Limb Occlusion Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620722
• Other study ID #: H14-02048
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: November 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tourniquet Safety and Effectiveness

Intervention

Device:
• Personalized Tourniquet Instrument
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.
• Handheld Doppler ultrasound
Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

Locations

Country	Name	City	State
Canada	BC Children's and Women's Hospital	Vancouver	British Columbia
Canada	Cambie Surgery Centre	Vancouver	British Columbia
Canada	Complex Joint Clinic, Vancouver General Hospital	Vancouver	British Columbia
Canada	Foot and Ankle Clinic, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Review. Erratum in: J Bone Joint Surg Am. 2010 Feb;92(2):442. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique		at time of measurement
Secondary	Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique		at time of measurement

External Links

•   Educational website about tourniquets