NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05672381

Enrollment

Registered

2023-01-05

Start date

2023-05-12

Completion date

2025-09-16

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compartment Syndrome of Forearm, Compartment Syndrome of Lower Leg, Compartment Syndromes

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.

Interventions

PROCEDURELower extremity and/or upper extremity surgery

Lower extremity and/or upper extremity surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Association of NIRST or ICG measurements with development of ACS	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026