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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Association of NIRST or ICG measurements with development of ACS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Association of NIRST or ICG measurements with development of ACS
时间窗: 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.
次要结局
未报告次要终点
研究者
Ida Leah Gitajn
Section Chief
Dartmouth-Hitchcock Medical Center