New Method for Real-time Detection of Tissue Ischemia; IscAlert™ - Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Tissue CO2-level
研究概览
简要总结
This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring CO2 in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlert™ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed. 250 Devices is planned to be used in this clinical study.
详细描述
This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery with tourniquet.
50 number of patients will be enrolled to undergo the procedures detailed in this clinical investigational plan using 250 devices.
IscAlert is 0.8 mm in diameter and in vitro testing, shows stable and accurate measurements of pCO2. More than 100 animal experiments have been done with the sensor. The experiments have shown that the sensor detects ischemia (Increased CO2-measurements) in real time in the following organs and tissues: Brain, heart, liver, kidneys, pancreas, intestines, musculature and subcutaneous tissue. Sensitivity and specificity are close to 100%. The sensors are inserted into tissue by a split needle technique. The split needle is the size of a 3-gauge peripheral venous catheter. In animal studies, no complications have been detected when using the sensor.
The IscAlert catheters are connected to an electronics unit that is fixed to the skin with an adhesive plaster outside the sterile area. The electrical signals are redirected to a PC approved for clinical use which continuously records tissue pressures of CO2.
IscAlert sensors (3 - three) are inserted into normal muscle and subcutaneous tissue proximal on the limb to be operated. The insertion is distal to the blood cuff, and far away from the surgery field. The insertion is done under sterile conditions in accordance with standard sterility criteria at the hospital. No pain during insertion will occur because of insertion is performed after anesthesia induction. Also, the insertion can be compared to an intramuscular injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients must be scheduled for orthopedic limb surgery with planned use of tourniquet.
- •Subject must be ≥ 18 years
- •Able to give written signed informed consent
- •Tourniquet planned to be used > 30 minutes
排除标准
- •Sign of inflammation/infection, hematoma, and traumatized tissue at insertion site
结局指标
主要结局
Tissue CO2-level
时间窗: 72 hours
Tissue CO2-level (kPa) during insertion periode
次要结局
- Pain score at insertion site - Numerical Rating Scale (NRS) - 7 days after discharge from hospital(7 days)
- Arterial pH level(3 hours)
- Duration of surgery(180 minutes)
- Infection(30 days)
- Arterial CO2 level(3 hours)
- Arterial lactate level(3 hours)
- End-tidal level of CO2(4 hours)
- Duration of anesthesia(240 minutes)
- Bleeding(72 hours)
- Arterial O2 level(3 hours)
- Time of tourniquet(180 minutes)
- Pain score at insertion site - Numerical Rating Scale (NRS) - 30 days after discharge from hospital(30 days)
- End-tidal level of CO2 72 hours(72 hours)
研究者
Magne Røkkum
Head Orthopaedic Department/Professor
Oslo University Hospital