Clinical trial NCT02620722: A New Technique for Determining Limb Occlusion Pressure
Official title: A New Technique for Determining Limb Occlusion Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourniquet Safety and Effectiveness
Keywords: tourniquet
safety
personalized
surgery
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 203
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
timeFrame: at time of measurement
Secondary outcomes:
measure: Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique
timeFrame: at time of measurement
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Complex Joint Clinic, Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Cambie Surgery Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Foot and Ankle Clinic, St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: James A McEwen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.