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

Acute Compartment Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123798
• Other study ID #: DR080018-01
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: June 14, 2011
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: J&M Shuler
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

Device:
• near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Locations

Country	Name	City	State
Germany	Landstuhl Regional Medical Center	Landstuhl

Sponsors (3)

Lead Sponsor	Collaborator
J&M Shuler	Somanetics Corporation, United States Department of Defense

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)		24-48 hours from hospital admission	No