Minimizing Tourniquet Pressures in Paediatric Orthopaedic Knee Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00439153
First received: February 21, 2007
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

Tourniquet cuffs are routinely used to stop blood flow in patients' arms or legs during surgery. This allows surgeons to better visualize anatomical structures during the procedure. Although complications after surgery are rare, patients sometimes suffer from pain or numbness in their limb and redness of the skin in the area where the cuff was applied. Using the lowest pressure possible minimizes the chance of these problems. Previous studies, conducted on adults, have shown that basing the cuff pressure on the minimum amount of pressure necessary to stop blood flow to the limb (known as limb occlusion pressure, or LOP) can lead to lower cuff pressures successfully being used. The goal of this study is to determine the magnitude by which tourniquet cuff pressure can be reduced in children using a tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs selected to fit the size and contour of the limb. The tourniquet instrument and cuffs used in this study are all commercially available and approved for use with children.

Hypothesis:

It is hypothesized that use of a commercially available tourniquet instrument capable of calculating limb occlusion pressure in combination with tourniquet cuffs selected and applied according to a standardized procedure will produce surgical fields of equal or superior quality with significantly lower tourniquet cuff pressures.


Condition Intervention
Anterior Cruciate Ligament Repair
Device: Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Quality of Surgical Field in Reconstructive Anterior Cruciate Ligament Surgery: Comparison of Tourniquet Cuff Pressure Determined by an Automated Limb Occlusion Pressure Measurement to a Standard Pressure of 300 mm Hg.

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Quality of surgical field [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average tourniquet cuff pressure [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Incidence of neurapraxias [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: September 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs
    See Detailed Description.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will be selected from the primary investigator's patients scheduled for anterior cruciate ligament repair surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00439153

Locations
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christopher Reilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00439153     History of Changes
Other Study ID Numbers: H06-03184
Study First Received: February 21, 2007
Last Updated: October 12, 2011
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on July 23, 2014