NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

September 30, 2025 updated by: Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower leg Trauma
High-energy lower leg trauma at risk for Acute Compartment Syndrome
Procedure: Lower extremity and/or upper extremity surgery
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
Lower extremity and/or upper extremity surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of NIRST or ICG measurements with development of ACS
Time Frame: 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Dartmouth College

Investigators

  • Principal Investigator: Ida L Gitajn, MD, MS, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Actual)

September 16, 2025

Study Completion (Actual)

September 16, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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