Clinical Trial: The Application of Near Infrared Spectroscopy (NIRS) in the Detection of Lower Limb Compartment Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Application of Near Infrared Spectroscopy (NIRS) in the Detection of Lower Limb Compartment Syndrome

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 criteria will be identified at time of admission by the receiving Trauma and Orthopaedics Registrar who will be trained in the study design and protocols.

Eligible individuals will be approached about participating in the study either at time of admission or shortly afterwards, either by the chief investigator or another doctor trained in the research protocol. Where the individual is unconscious or otherwise incapacitated, which is likely in many major trauma victims, inclusion in the study will be discussed with the patient's legal representative and/or family.

The consent process for the study will consist of having the study protocol explained by either the chief investigator, or another doctor trained in the study design. Patients will be allowed to read a participant information sheet, and permitted as much time as they require to decide if they wish to participate in the study. Verbal and written consent will be taken using a study specific consent form.

In the case of incapacitated patients, the study design will be explained to their relatives' legal representatives as appropriate and advice sought from them as to whether they know of any reason why the patient might object to participate in the study. Upon regain capacity consent will be sought from the patient for storage and analysis of their study data.

Once consented, the patient will undergo monitoring with both continuous compartment pressures, and NIRS measurements.

Rec

Detailed Summary:
Sponsor: University Hospital Birmingham NHS Foundation Trust

Current Primary Outcome:

  • Absolute limb StO2 at limb perfusion pressures ≤ 30 mmHg. [ Time Frame: Hourly ]
  • Control corrected limb StO2 at limb perfusion pressures ≤ 30 mmHg. [ Time Frame: Hourly ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation between absolute limb StO2 and limb perfusion pressures. [ Time Frame: Hourly ]
  • Correlation between control corrected limb StO2 and limb perfusion pressures. [ Time Frame: Hourly ]
  • Incidence of compartment syndrome in study population. [ Time Frame: 24 hours ]
  • Survival to discharge. [ Time Frame: 30 days ]


Original Secondary Outcome: Same as current

Information By: University Hospital Birmingham NHS Foundation Trust

Dates:
Date Received: June 15, 2009
Date Started: September 2009
Date Completion:
Last Updated: September 20, 2011
Last Verified: September 2011