NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

Recruiting

• Conditions: Compartment Syndromes; Compartment Syndrome of Lower Leg; Compartment Syndrome of Forearm
• Interventions: Procedure: Lower extremity and/or upper extremity surgery

• Registration Number: NCT05672381
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2023-05-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Forearm Trauma	Lower extremity and/or upper extremity surgery	High-energy forearm trauma at risk for Acute Compartment Syndrome
Lower leg Trauma	Lower extremity and/or upper extremity surgery	High-energy lower leg trauma at risk for Acute Compartment Syndrome

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States