Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients With an Upper or Lower Extremity Fracture at Risk for Acute Compartment Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.
研究概览
简要总结
Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions to avoid complications. Unfortunately, the subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve the investigator's ability to diagnose this potentially devastating condition. The purpose of this trial is to evaluate the safety and functionality of MY01, an investigational device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. This is a single centre, non-randomized, non-controlled, unblinded, prospective trial of the MY01 device. A cohort of 25 participants will be prospectively enrolled to document the performance of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 16-
- •Fracture of the tibia, foot, forearm, femur, or humerus that is felt by the surgeon to have a reasonable indication that elevated intracompartmental pressure could occur in the patient.
- •Planned admission to hospital (to enable monitoring of compartment pressures)
- •Provision of informed consent to participate.
排除标准
- •Frankly contaminated or infected wounds or fractures.
- •Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- •Current or pre-existing neuropathy in the study limb.
- •Pregnant women.
研究组 & 干预措施
MY01 Device
Device: MY01 Device
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
干预措施: MY01 Continuous Compartmental Pressure Monitor (Device)
结局指标
主要结局
Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.
时间窗: 24-48 hours following device insertion.
At insertion of device the physician will complete a feedback questionnaire on the device, the participant will be assessed for adverse events, and routine assessment will be performed.
The change in intracompartmental pressure.
时间窗: 24-48 hours following device insertion.
Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's \[Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia\]), and compared against the pressure readout \[mmHG\] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.
Clinical ease with which the MY01 device is able to be inserted into a compartment.
时间窗: 24-48 hours following device insertion.
At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you that the sensor is in the correction position?" \[1 = uncertain\] - \[5 = very certain\]. The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 5 should be considered a positive scenario, whereas a record of 1 should indicate a negative scenario.
次要结局
- Adverse events associated with the use of the device.(24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment.)
- Pain at insertion site.(24-48 hours following device insertion.)