A New Technique for Determining Limb Occlusion Pressure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02620722

Enrollment

203

Registered

2015-12-03

Start date

2014-09-30

Completion date

2019-12-31

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourniquet Safety and Effectiveness

Keywords

tourniquet, safety, personalized, surgery

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

Interventions

DEVICEPersonalized Tourniquet Instrument

Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.

DEVICEHandheld Doppler ultrasound

Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026