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Completed

NCT Number: NCT05672381

NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

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.

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Key information

Conditions

Compartment Syndromes Cardiovascular Diseases Compartment Syndrome of Forearm Compartment Syndrome of Lower Leg Muscular Diseases Musculoskeletal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lower extremity and/or upper extremity surgery

Procedure

Lower extremity and/or upper extremity surgery

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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