NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

Compartment Syndromes Clinical Trial

Official title:

Near-infrared Spectroscopic Tomography (NIRST) and ICG-based Perfusion Imaging to Diagnose and Assess Muscle Viability in High Energy Trauma at Risk for Acute Compartment Syndrome: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672381
• Other study ID #: STUDY02001595
• Status: Recruiting
• Start date: May 12, 2023
• Est. completion date: January 2027

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Holly B Symonds
• Phone: 603-653-9440
• Email: Holly.B.Symonds[@]hitchcock.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings:

• Pain out of proportion to visible findings

• Escalating doses of pain medication

• Pain with passive stretch of toes and/or fingers

• Pallor, paresthesias, pulselessness

• Tense soft tissues

• High energy tibia or forearm fracture

• Provision of informed consent

Exclusion Criteria:

• History of allergy to ICG and/or iodine

• Pregnant women or nursing mothers

• Any patient with an open wound for whom NIRST device cannot be applied >4cm from the open wound will be excluded from NIRST imaging.

Related Conditions & MeSH terms

• Compartment Syndromes
• Syndrome

Intervention

Procedure:
• Lower extremity and/or upper extremity surgery
Lower extremity and/or upper extremity surgery

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of NIRST or ICG measurements with development of ACS	The primary objective of this work is to determine whether total hemoglobin, oxygen saturation and water content imaged by NIRST or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.	36 months