Minimizing Tourniquet Pressures in Paediatric Orthopaedic Knee Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00439153|
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : October 14, 2011
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.
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 or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Repair||Device: Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
- Device: Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs
See Detailed Description.
- Quality of surgical field
- Average tourniquet cuff pressure
- Incidence of neurapraxias
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439153
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Christopher Reilly, MD||University of British Columbia|