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

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

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Holly B Symonds; Phone Number: 603-653-9440; Email: Holly.B.Symonds@hitchcock.org
• Study Contact Backup: Name: Devin S Mullin; Phone Number: 603-650-6032; Email: Devin.S.Mullin@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Holly B Symonds; Phone Number: 603-653-9440; Email: Holly.B.Symonds@hitchcock.org
      • Contact: Devin S Mullin; Phone Number: 603-650-6032; Email: Devin.S.Mullin@hitchcock.org
      • Principal Investigator: Ida L Gitajn, MD

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

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	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

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Dartmouth College
• Investigators: Principal Investigator: Ida L Gitajn, MD, MS, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

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 (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• 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