Using imaging techniques to assess 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 study is testing if special imaging techniques can help doctors spot early signs of muscle damage in patients suspected of having Acute Compartment Syndrome before it gets worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05672381 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients suspected of having Acute Compartment Syndrome, a condition where increased pressure within a muscle compartment can lead to muscle and nerve damage. The study aims to evaluate the relationship between changes in near-infrared spectroscopy (NIRST) signals, which reflect blood oxygen levels, and indocyanine green (ICG) fluorescence signals, which indicate tissue perfusion. By analyzing these signals, researchers hope to identify at-risk soft tissue and muscle before significant damage occurs. The study involves patients undergoing lower or upper extremity surgery based on clinical assessment by orthopedic providers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinical suspicion of Acute Compartment Syndrome based on specific orthopedic assessments.
Not a fit: Patients with a history of allergy to ICG or iodine, pregnant or nursing women, and those with open wounds unsuitable for NIRST imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of Acute Compartment Syndrome, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While the use of NIRST and ICG for perfusion imaging is gaining interest, this specific approach in the context of Acute Compartment Syndrome is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Ida L Gitajn, MD, MS — Dartmouth-Hitchcock Medical Center
- Study coordinator: Holly B Symonds
- Email: Holly.B.Symonds@hitchcock.org
- Phone: 603-653-9440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.