NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-12

Study Completion Date

2025-09-16

Brief Summary

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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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Detailed Description

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Conditions

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Compartment Syndromes Compartment Syndrome of Lower Leg Compartment Syndrome of Forearm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lower leg Trauma

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

Lower extremity and/or upper extremity surgery

Intervention Type PROCEDURE

Lower extremity and/or upper extremity surgery

Forearm Trauma

High-energy forearm trauma at risk for Acute Compartment Syndrome

Lower extremity and/or upper extremity surgery

Intervention Type PROCEDURE

Lower extremity and/or upper extremity surgery

Interventions

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Lower extremity and/or upper extremity surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No