Clinical Safety and Feasibility Study for Non-CE Marked Medical Device: Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Device synchronization success rate
研究概览
简要总结
Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs. To date, there is no practical, non-invasive technology that offers synchronized, personalized electrostimulation for both inspiratory and expiratory muscles during mechanical ventilation.
Heecap is a medical product designed to provide transcutaneous electrical stimulation of the respiratory muscles (TERM) that are involved in inspiration and expiration, detecting those in which it is clinically relevant and safe to provide such stimulation in assisted respiration.
The following study aims to evaluate the safety and preliminary performance of the stimulation algorithm in mechanically ventilated patients in the ICU. This evaluation will specifically focus on the algorithm's ability to synchronize stimulation with the patient's breathing patterns, and on evaluating the safety and feasibility of the TERM in activating respiratory muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patient population 1
- •Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to enrollment.
- •Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.
- •Patient population 2
- •Adult patients with acute hypoxemic respiratory failure who have been under pressure support mechanical ventilation for at least 24 hours prior to enrollment.
- •Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.
排除标准
- •Patients treated with neuromuscular blocking agents
- •Patients with neuromuscular disease
- •Patients with a pacemaker or past history of arrhythmia
- •Patients with physical obstacles that prevent thoracic or abdominal electrostimulation (e.g., abdominal trauma, recent abdominal surgery, polytrauma, broken or irritated skin)
- •BMI > 40 kg/m2
- •Hemodynamically unstable (noradrenaline >0.1 microgram/kg/min)
- •Pregnancy
- •Patients under the age of 18
- •The formalized ethical decision to withhold or withdraw life support
- •Patient under guardianship
- •Patients deprived of liberties
- •Patients already enrolled in the present study, in a previous episode of acute respiratory failure.
- •The patient who does not consent.
研究组 & 干预措施
Mechanical ventilated patients in ICU
Single arm for device-treated patients
干预措施: Heecap (Device)
结局指标
主要结局
Device synchronization success rate
时间窗: through study treatment phase completion (up to 3 days)
Device feasibility in correctly stimulating breaths measured by the % of correct stimulated breaths of total breaths stimulated. All stimulated breaths will be analyzed and categorized as correctly stimulated or incorrectly stimulated.
次要结局
- Incidence of AEs/SAEs(through study completion (up to 4 days))
- Transdiaphragmatic pressure (PDi)(During TERM on day 1 and day 2)
- Muscle thickening fraccion(Day 1 and day 2 of treatment)
- Occlusion pressure (Pocc)(Day 1 and day 2)