The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of acute compartment syndrome (ACS)
研究概览
简要总结
This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. We hypothesize that:
- NIRS values will be well-correlated with intracompartmental pressure measurements
- NIRS values will be significantly different between non-injured and injured extremities, and injured extremities treated with fasciotomy for acute compartment syndrome.
- NIRS values of the upper extremity and feet will correlate to values from normal legs in critical control patients and patients with unilateral sever lower extremity injuries.
详细描述
The purpose of this prospective observational cohort study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. Additionally, it will establish diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring. Through prospective measurements of NIRS values, vital signs, intracompartmental pressures and clinical examinations, guidelines and parameters will be established for the use of NIRS in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS.
Null hypotheses:
- NIRS values do not correlate with intracompartmental pressures, when they are obtained in the course of routine care of patients in the combat theater.
- There is no difference in the NIRS values between non-injured, injured extremities and injured extremities treated with fasciotomy for ACS
- NIRS values from the upper extremity and feet do not correlate to NIRS values from the normal legs in critical control patients and patients with unilateral severe lower extremity injury.
Specific Aims:
- Conduct observational, human-use, study to compile a normative reference database for NIRS-measured tissue perfusion in the uninjured upper extremity and the injured and non-injured legs of up to 120 injured subjects, from varying ethnicities (skin pigmentations) in varying degrees of hemodynamic status (stable, critically injured) to test the 3 hypotheses listed above. The study groups consist of one control group (critically ill without leg injuries) and one investigational group (critically injured with leg injuries):
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subjects
- •between the ages of 15 and 65 years old
- •(Cohort 1 only) Admitted directly to the ICU of a participating study site
- •(Cohort 2 only) Admitted to a participating study site with the following injury/mechanism combinations:
- •Segemental tibia shaft fracture
- •Comminuted tibia shaft fracture
- •Schatzker Type III-VI tibial plateau fractures
- •Mechanisms:
- •Fall from a height of >= 8 feet
- •Motor vehicle or motorcycle crash
- •Pedestrian versus automobile
排除标准
- •Patients, in whom application of NIRS monitoring is viewed as an impediment to care.
- •Patients with known prior leg fractures (not related to current injury)
- •History of peripheral vascular disease or lower extremity vascular surgery.
- •Amputation
- •Diagnoses with ACS prior to enrollment
- •Spinal injuries resulting in complete loss of function
- •Mangled lower extremity
- •Bilateral upper extremity injuries
结局指标
主要结局
Incidence of acute compartment syndrome (ACS)
时间窗: 24-48 hours at study site
The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.
次要结局
- Intracompartmental pressure (ICP)(24-48 hours at study site)