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

NCT00921271 | Completed

• 1 other identifier: RRK3786
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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. Recordings for both techniques will be taken each hour, as part of the patients normal observations, from the point of consent until 24 hours after their first operation. Where patients do not have an operation the total duration of monitoring will be 24 hours. The measurements will be taken by nursing staff who have received training in both techniques. The procedure for each technique is described below:

1. 1.Continuous compartment pressures will be recorded in the broken leg, in case of tibial fractures, in all other patients fitting the inclusion criteria measurements will be taken from both legs (as both legs are at risk of compartment syndrome).
2. 2.NIRS measurements will be taken with an the INVOS system, produced by Somentics. These measurements will be taken from both legs, the affected leg and other other leg used as a control for comparison. Where both legs are at risk measurements will be taken from both legs and the midpoint of the forearm used as a control.

Conditions

Compartment Syndrome

Keywords

Compartment syndrome

Outcome Measures

Primary Outcomes (2)

• Absolute limb StO2 at limb perfusion pressures ≤ 30 mmHg.

  Hourly

• Control corrected limb StO2 at limb perfusion pressures ≤ 30 mmHg.

  Hourly

Secondary Outcomes (4)

• Correlation between absolute limb StO2 and limb perfusion pressures.

  Hourly

• Correlation between control corrected limb StO2 and limb perfusion pressures.

  Hourly

• Incidence of compartment syndrome in study population.

  24 hours

• Survival to discharge.

  30 days

Study Arms (1)

At risk for compartment syndrome.

Patients admitted to Selly Oak Hospital, Birmingham, Uk, meeting one or more of the following inclusion criteria: 1. 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. 2. Any patient sustaining a traumatic injury with a base deficit ≥ 6 mEq/L within 12 hours of Hospital admission. 3. Any patient receiving ≥ 6 units packed red blood cells within 12 hours of hospital admission.

Device: Monitoring of StO2

Interventions

Monitoring of StO2 DEVICE

Monitoring of lower limb anterior compartment StO2, taking measurements on an hourly basis for the duration of the study protocol.

Also known as: INOVOS system.

At risk for compartment syndrome.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to Selly Oak Hospital (Secondary care) meeting the study inclusion criteria.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

Selly Oak Hospital

Birmingham, West Midlands, B29 6JD, United Kingdom

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tom Barker, MBChB, MRCS

  University Hospitals Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

GB (1)