Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tissue CO2-level
研究概览
简要总结
This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.
详细描述
This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.
The study will provide information regarding the clinical usefulness of tissue perfusion assessment by pCO2 and temperature monitoring in the diagnosis of patients at risk of developing acute compartment syndrome. Additionally, it will provide information regarding limits of pCO2 and temperature in the tissue indicating the need for fasciotomy. A fasciotomy will be performed independent of the measured pCO2 and temperature measurements in the muscle if clinical signs indicate a development of possible acute compartment syndrome. Measures of pain, and number of infections and bleeding caused by (or assumed to be caused by IscAlert) at insertion site will be registered.
The duration of investigation: In a patient: From insertion of first IscAlert™ sensor(s) to discharge from hospital. The sensors will usually be implanted for two days each. Follow up until 30 days after discharge from the hospital. 13 months of inclusion of all patients. There will be one last follow-up visit 1 year after discharge which will only look at sequelae after acute compartment syndrome and not sensors related issues.
Primary Aim: To assess if pCO2-levels when assessed with IscAlert correctly indicate the presence of acute compartment syndrome in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.
Hypotheses
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a leg fracture that, perceived by the clinician, could give rise to later developing acute compartment syndrome condition.
- •Subject must be 18 years or more.
- •Able to sign informed consent.
- •Expected cooperation of the patients for the treatment and follow up
排除标准
- •Another study interfering with current study
- •Any reason why, in the opinion of the investigator, the patient should not participate.
- •Patients where a fasciotomy has already been decided should be performed
结局指标
主要结局
Tissue CO2-level
时间窗: 10 days
Tissue CO2-level (kPa) during insertion period
次要结局
- Incidence of death 1 year(1 year)
- Pain in the lower leg during hospitalisation(10 days)
- Time to discovery of reduced blood flow in lower leg(10 days)
- Number of limb amputations performed(1 year)
- Bleeding(10 days)
- Infection(30 days)
- Pain at sensor insertion site(30 days)
- Color of the lower leg(10 days)
- Paresthesia of the lower leg(10 days)
- Number of sensory deficit conditions(1 year)
- Number of paralysis conditions(1 year)
- Number of rhabdomyolysis conditions(1 year)
- Number of limb muscle contractures(1 year)
- Incidence of death during hospitalisation(30 days)
- Number of pack-years(30 days)
- Intravenous fluid(12 hours)
- Vasoactive drugs(12 hours)
- Paralysis of the lower leg(10 days)
- Lenght of sensor implantation time(10 days)
- Number of re-operations(30 days)
- Number of skin grafts performed(1 year)
- Number of acute compartment syndrome conditions during hospitalisation(30 days)
- Number of acute compartment syndrome conditions after 1 year(1 year)
- Lenght of stay during primary hospitalisation(30 days)
- Tissue temperature level(10 days)
- IscAlert functionality(10 days)
- Diastolic blood pressure during hospitalisation(10 days)
- Peripheral pulse during hospitalisation(10 days)
- Intracompartmental pressure(10 days)
- Systolic blood pressure during hospitalisation(10 days)
- Hemoglobin(10 days)
- Creatine kinase(10 days)
研究者
John Clarke-Jenssen
Chief Consultant
Oslo University Hospital