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OpenTrials
Completed

NCT Number: NCT02620722

A New Technique for Determining Limb Occlusion Pressure

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.

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Key information

Conditions

Tourniquet Safety and Effectiveness

Age range

3 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's and Women's Hospital, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Tourniquet Instrument

Device

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

Handheld Doppler ultrasound

Device

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

Primary outcomes

  1. Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique

    Time frame: at time of measurement

Secondary outcomes

  1. Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique

    Time frame: at time of measurement

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2015
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.