The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

Completed

• Conditions: Acute Compartment Syndrome
• Interventions: Device: near-infrared spectroscopy

• Registration Number: NCT01123798
• Lead Sponsor: J&M Shuler

Brief Summary

The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 18-65 years old
• male or female
• active duty servicemen who have been evacuated from OIF or OEF through LRMC

Exclusion Criteria

• patients not willing to provide consent
• patients in whom application of NIRS monitoring is viewed as an impediment to casualty care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critical controls	near-infrared spectroscopy	Critically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the "shock" physiological status.
Stable controls	near-infrared spectroscopy	Uninjured soldiers to provide normative data for stable physiological status
Lower extremity trauma	near-infrared spectroscopy	Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.

Primary Outcome Measures

Name	Time	Method
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)	24-48 hours from hospital admission

Trial Locations

Locations (1)

Landstuhl Regional Medical Center; 🇩🇪 Landstuhl, Germany