A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes in PaO2/FiO2 ratio
研究概览
简要总结
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).
详细描述
The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to the phrenic nerves, which in turn causes the diaphragm muscle to contract, the PROTECT DPTS is intended to protect the diaphragm from atrophy and preserve lung mechanics to reduce lung inflammation and injury associated with short-term mechanical ventilation. Sustained lung and diaphragm health during early mechanical ventilation is expected to reduce the risk of comorbidities, improve clinical outcomes such as weaning success, and thereby reduce the number of patients who require prolonged mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Are 18 years or older
- •Have been mechanically ventilated due to moderate ARDS for 48-120h
- •Have a PaO2/FiO2 ratio < 200 and > 100 at the time of screening with PEEP ≥ 5 cmH2O
- •Are expected to remain on mechanical ventilation ≥ 48 hours
- •Are under continuous sedation with Richmond Agitation Sedation Scale (RASS) ≤ -3
排除标准
- •Septic shock with hemodynamic instability (norepinephrine or epinephrine < 0.5 gamma/kg/min)
- •Catheter access to left subclavian vein deemed impossible
- •Use of neuromuscular blocking agents within last 12 hours
- •Bacteremia within the last 48 hours or uncontrolled source of infection
- •Currently on ECMO
- •Enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study
- •Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles
- •BMI >45 kg/m2
- •Known or suspected phrenic nerve paralysis
- •Any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer PROTECT DPTS, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators
- •No affiliation to the French health insurance system
- •Under curatorship
- •Imprisoned
- •Known or suspected to be pregnant or lactating
结局指标
主要结局
Changes in PaO2/FiO2 ratio
时间窗: Day 1
The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.
次要结局
- Regional lung ventilation(Day 1)
- Successful LIVE catheter placement(Day 1)
- Regional lung atelectasis(Day 1)
- Alveolar-arterial (A-a) gradient(Day 1)
- Cardiac output index(Day 1)
- Serious adverse events(Day 5)