Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of titrating tidal volume < 6 ml/kg
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV.
Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •age > 18 year
- •informed consent
- •ARDS according to the Berlin definition
- •RASS -4/-5
- •tidal volume > 8 ml/kg during supported ventilation
- •double balloon esophageal EMG NAVA catheter
排除标准
- •recent use of muscle relaxants / NMBAs (< 3 hours)
- •pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases
- •phrenic nerve lesions
- •elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma)
- •open chest or abdomen
- •pregnancy
- •systolic blood pressure < 90 mm Hg / MAP < 65 mm Hg
研究组 & 干预措施
Neuromuscular blocking agent
干预措施: Rocuronium (Drug)
结局指标
主要结局
Feasibility of titrating tidal volume < 6 ml/kg
时间窗: Within 5 minutes after titration of NMBA
The feasibility of titrating tidal volume in ARDS patients below 6 ml/kg using NMBA is evaluated in every patient. The outcome measure is dichotomic (yes/no).
次要结局
- Respiratory rate(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA)
- Diaphragm electrical activity(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
- Transpulmonary pressure(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
- Transdiaphragmatic pressure(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
- Neuroventilatory efficiency(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
- Neuromechanical efficiency(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
- Patient-ventilator contribution to breathing(During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA)
- Oxygenation index(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
- Carbon dioxide tension in arterial blood (PaCO2)(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
- pH of arterial blood(Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.)
- Patient-ventilator interaction(Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.)
研究者
Leo Heunks
L. Heunks, MD PhD
University Medical Center Nijmegen