NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

NCT05672381 | Completed

• 1 other identifier: STUDY02001595
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compartment Syndromes; Compartment Syndrome of Lower Leg; Compartment Syndrome of Forearm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lower leg Trauma

High-energy lower leg trauma at risk for Acute Compartment Syndrome

Procedure: Lower extremity and/or upper extremity surgery

Forearm Trauma

High-energy forearm trauma at risk for Acute Compartment Syndrome

Procedure: Lower extremity and/or upper extremity surgery

Interventions

Lower extremity and/or upper extremity surgery PROCEDURE

Lower extremity and/or upper extremity surgery

Forearm Trauma; Lower leg Trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects receiving care at DHMC (Lebanon) with high energy lower leg or forearm trauma at risk for Acute Compartment Syndrome.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ida L Gitajn, MD, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: May 12, 2023
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: October 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)