Minimizing Tourniquet Pressures in Paediatric Orthopaedic Knee Surgery
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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. |
- Quality of surgical field [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- 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) |
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Device: Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All subjects will be selected from the primary investigator's patients scheduled for anterior cruciate ligament repair surgery
Contacts and Locations| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3N1 | |
| 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 June 13, 2013