Status:
COMPLETED
The Application of Near Infrared Spectroscopy (NIRS) in the Detection of Lower Limb Compartment Syndrome
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Conditions:
Compartment Syndrome
Eligibility:
All Genders
16+ years
Brief Summary
This study aims to determine how infrared spectroscopy compares to continuous compartment pressure monitoring in the detection of compartment syndrome. Individuals meeting the study eligibility crite...
Eligibility Criteria
Inclusion
- Patients with one or more of the following injuries:
- tibial fracture
- crush injury/soft tissue injury to lower limb without fracture
- pelvic fracture
- major vascular injury below the aortic bifurcation
- 2 or more long bone fractures
- Any patient sustaining a traumatic injury with a base deficit ≥ 6 mEq/L within 12 hours of Hospital admission.
- Any patient receiving ≥ 6 units packed red blood cells within 12 hours of hospital admission.
Exclusion
- Age ≤ 16 years are excluded by design, as all pediatric cases are managed at Birmingham Childrens Hospital. There is no upper age limit.
- Bilateral lower limb amputees.
- Individuals who have received methylene blue within the previous week or during the study period.
- Patient refusal to participated in the trial.
- In the case of incapacitated patients, refusal by the patient's relatives/representatives, or where no representative can be identified.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00921271
Start Date
September 1 2009
End Date
April 1 2011
Last Update
September 21 2011
Active Locations (1)
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1
Selly Oak Hospital
Birmingham, West Midlands, United Kingdom, B29 6JD