Partial Neuromuscular Blockade to Facilitate Lung and Diaphragm Protective Mechanical Ventilation in Intensive Care Unit Patients: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The percentage of breaths with tidal volume 6ml/kg predicted body weight (PBW)
研究概览
简要总结
Controlled mechanical ventilation may lead to the development of diaphragm muscle atrophy, which is associated with weakness and adverse clinical outcome. Therefore, it seems reasonable to switch to partially supported ventilator modes as soon as possible. However, in patients with high respiratory drive, the application of partially supported modes may result in high lung distending pressures and diaphragm injury.
Recently, the investigators published a study that demonstrated that a low dose of neuromuscular blocking agents (NMBA) facilitates lung-protective ventilation and maintains diaphragm activity in intensive care unit (ICU) patients. That study was conducted in a small (N=10), selected group of patients and partial neuromuscular blockade was applied for only 2 hours (proof-of-concept study). Therefore, further research has to be done before this strategy can be applied in clinical practice.
The primary goal is to investigate the feasibility and safety of prolonged (24 hours) partial neuromuscular blockade in patients with high respiratory drive in partially supported mode. The secondary goals are to evaluate the effect of this strategy diaphragm function, lung injury, hemodynamics and systemic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •high respiratory drive, defined as tidal volume > 8ml/kg PBW on inspiratory support of 12 cmH2O.
- •sedation level: richmond agitation-sedation scale (RASS) ≤ -3
- •ventilated in pressure support mode
排除标准
- •recent use of NMBA (< 2 hrs)
- •arterial pH < 7.25
- •hemodynamic instability, i.e. high dose vasopressors (>0.5 μg/kg/min) or inotropes (dobutamine >15 μg/kg/min or enoximone >25 μg/kg/min)
- •intracranial pressure > 20 cmH2O
- •past medical history of neuromuscular disorders
- •known pregnancy
- •known previous anaphylactic reaction to NMBA's.
研究组 & 干预措施
Rocuronium
Titration of rocuronium bromide until tidal volume of 6ml/kg predicted body weight (PBW) is reached
干预措施: Rocuronium Bromide (Drug)
结局指标
主要结局
The percentage of breaths with tidal volume 6ml/kg predicted body weight (PBW)
时间窗: At five time points of 1hr during the first 24hrs of the study period
During the study period we measure at five time points of 1 hour (T0, T1, T5, T12, T24) all breaths and determine the percentage of breaths with a tidal volume of 6ml/kg PBW.
Incidence of directly related serious adverse events
时间窗: During the 48hrs study period
A serious adverse event is any untoward medical occurence or effect that: * results in death * is life threatening * requires prolongation of existing inpatients' hospitalization * results in persistent or significatn disability or incapacity * is a new event of the trial medication to affect the safety of the subjects, such as adverse events which are not already were described
次要结局
- Number of patients completing the study without meeting the stopping criteria(At four time points during the first 24hrs of the study period)
- Effect on partial carbon dioxide (pCO2)(During the 48hrs study period)
- Effect on pH(During the 48hrs study period)
- Effect on heart rate(During the 48hrs study period)
- Effect on blood pressure(During the 48hrs study period)
- Effect on respiratory rate(During the 48hrs study period)
- Effect on pressure time product (PTP)(During the first 24hrs of the study period)
- Effect on peripheral capillary oxygen saturation (SpO2)(During the 48hrs study period)
- Effect on partial oxygen pressure (pO2)(During the 48hrs study period)
- Effect on work of breathing (WOB)(During the first 24hrs of the study period)
- Effect on tumor necrosis factor (TNF)-alfa(During the first 24hrs of the study period)
- Effect on interleukin(IL)-6 and IL-8(During the first 24hrs of the study period)
- Amount of days on mechanical ventilation(Until 30 days after the end of the study period)
研究者
Diana Jansen
Collaborating investigator
Amsterdam UMC, location VUmc