Can Near Infrared Spectroscopy (NIRS) or Intramuscular Glucose Monitoring (IMGM) Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures? "Proof of Concept" Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Use of point-of-care IM glucose to document relative hypoglycemia in the anterior compartment of the affected leg as an indicator of ACS and/or tissue ischemia.
研究概览
简要总结
Near infrared spectroscopy (NIRS), a technique that relies on differential absorption of infrared light to provide relative estimation of tissue oxygenation, has been successfully used to monitor perfusion of various tissues, including muscle tissue of the lower extremity, however available research reports mixed success and this technology is not currently a standard of care for patients with leg fractures.
The investigators propose use of NIRS technology in patients with diagnosis of tibial fracture and acute compartment syndrome to detect / document impaired perfusion of the anterior compartment of the leg, as compared to their non-broken leg. The investigators also propose measurement of intramuscular glucose level in the affected leg and compare it to a fingerstick glucose to detect relative hypoglycemia in the affected muscular compartment. If proven effective, NIRS, or IM glucose, or both techniques could be used for clinical monitoring of patients with tibial fractures at risk for acute compartment syndrome.
详细描述
Inclusion criteria:
- Patient's age: 18 - 75 years old
- Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
- Unilateral injury (i.e. only one leg is affected)
- Depth of anterior compartment of the leg < 2.5 cm (as measured by ultrasound) Study size - 7-10 patients
Procedure of enrollment:
When diagnosis of tibial fracture with vascular compromise or established ACS is made by the ED physician and confirmed by the Orthopedic surgeon, study team will be notified immediately (by the orthopedic service).
Study team member will approach the study candidate, explain the purpose of the study and obtain the informed consent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age to 75 years of age
- •Diagnosis of tibial fracture or fracture-dislocation complicated by diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
- •Unilateral injury (i.e. only one leg is affected)
- •Depth of anterior compartment of the leg < 2.5 cm (as measured by ultrasound) 6) Willing to consent to the study
排除标准
- •Younger than 18 years of age or over 75 years of age
- •Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
- •Depth to the muscle more than 3 cm as assessed with ultrasound.
- •History of fasciotomy performed on the affected leg.
- •Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
- •Language barrier- Inability to read or understand spoken English
结局指标
主要结局
Use of point-of-care IM glucose to document relative hypoglycemia in the anterior compartment of the affected leg as an indicator of ACS and/or tissue ischemia.
时间窗: once, intraoperatively
When incision is made by the surgeon, upon entering the anterior muscular-fascial compartment, surgeon will obtain small drop of blood (by aspiration with a 2 ml syringe from the cut surface of the muscle) and pass it on to the study personnel to apply it onto the test strip for glucose measurement. At the same time fingerstick will be performed and capillary glucose will be measured. Both glucose readings will be recorded. If intramuscular glucose readings in the affected extremity show relative hypoglycemia, i.e. glucose in the affected compartment will be lower than the fingerstick performed at the hand at the same time, that will prove that intramuscular glucose monitoring can be used to detect acute compartment syndrome and muscular ischemia.
Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise.
时间窗: 72 hours
NIRS sensors will be applied to the skin overlying anterior compartment of the injuries and uninjured legs. Uninjured leg will serve as a control leg. Readings from both legs will be recorded continuously until patient enters OR for emergent surgery. At that point NIRS sensor will be removed to allow skin prep for surgical procedure. NIRS sensor will be re-applied to the skin at the completion of the surgery before leg is wrapped with the dressing. Monitoring of both extremities will be continued for 72 hours. If NIRS readings of the affected extremity will be reliably lower as compared to unaffected extremity, and that difference will reverse after surgery (fasciotomy), where NIRS reading of the affected extremity should be at least equal to or, most likely, higher than those of the unaffected extremity, that will prove that NIRS monitoring can be used to detect acute compartment syndrome and muscular ischemia.
次要结局
未报告次要终点