The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Successful extubation within 14 days after randomization
研究概览
简要总结
This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.
详细描述
Objective: to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and RASS score compared with conventional sedation strategy (targeting RASS score alone) in patients requiring mechanical ventilation in the medical intensive care unit
The main questions it aims to answer are:
• Will titration of sedation targeting optimal respiratory drive assessed by P0.1 and arousal level improve outcomes in patients requiring mechanical ventilation in the medical ICU?
Study protocol Mechanically ventilated patients admitted to the medical ICU will be screened daily by the investigators. If the patients meet the eligibility criteria, they will be informed about the study protocol and potential risks and undergo informed consent. Then patients will be randomized in a 1:1 ratio and allocated to each study group (intervention and control group).
- After allocation, patients will be monitored for arousal level using RASS score and respiratory drive by P0.1 measured automatically from mechanical ventilators during the study period.
- Sedation and neuromuscular blocking agents used will be adjusted according to the group to which patients are allocated.
- Intervention group: Adjustment of sedation and neuromuscular blocking agents to achieve the target of light sedation (RASS 0 to -2) and optimal P0.1 (1.5 to 3.5 cmH2O) for 48 hours
- Control group: Adjustment of sedation to achieve the target of light sedation (RASS 0 to -2) alone for 48 hours
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
- •Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital
- •Age ≥18 years old
- •Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)
排除标准
- •Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients
- •Patients receiving mechanical ventilation for >72 hours before enrollment
- •Patients receiving neuromuscular blocking agents prior to randomization
- •Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy
- •Patients with severe metabolic acidosis (arterial pH <7.2) who do not have a plan for renal replacement therapy
- •Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases
- •Post-cardiac arrest patients
- •Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C
- •Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs
- •Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
- •Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment
研究组 & 干预措施
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Titrating sedation targeting both optimal P0.1 and appropriate arousal level (Procedure)
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Fentanyl (Drug)
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Midazolam (Drug)
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Propofol (Drug)
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Dexmedetomidine (Drug)
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
干预措施: Cisatracurium (Drug)
结局指标
主要结局
Successful extubation within 14 days after randomization
时间窗: 14 days after randomization
Successful extubation within 14 days without reintubation within 28 days after ICU admission
次要结局
- PaO2/FiO2 ratio on day 3 after randomization(3 days after randomization)
- 28-day mortality after randomization(28 days after randomization)
- Hospital all-cause mortality(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days)
- Successful extubation within 28 days after randomization(28 days after randomization)
- Duration of mechanical ventilation(From date of intubation until the date of last successful extubation or date of death from any cause, whichever came first, assessed up to 28 days)
- Self extubation rate at 7 days after extubation(7 days after randomization)
- Post-extubation respiratory failure(From date of randomization until the date of the first event of post-extubation respiratory failure or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days)
- Tracheostomy(From date of randomization until the date of tracheostomy or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days)
- ICU all-cause mortality(From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 days)
- PaO2/FiO2 ratio on day 7 after randomization(7 days after randomization)
- Delirium during ICU admission(From date of randomization until the date of diagnosis of delirium diagnosis or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days)
- Maximum infusion dose (per hour) of sedation(From date of sedation initiation until the date of sedation discontinuation or date of death from any cause, whichever came first, assessed up to 28 days)
- Duration (days) of sedation(From date of sedation initiation until the date of sedation discontinuation or date of death from any cause, whichever came first, assessed up to 28 days)
- Ventilator-associated pneumonia(From date of randomization until the date of first diagnosed ventilator-associated pneumonia or date of death from any cause, whichever came first, assessed up to 28 days)
- Successful extubation within 7 days after randomization(7 days after randomization)
- Ventilator-free days to day 28 after randomization(28 days after randomization)
- Reintubation rate at 7 days after randomization(7 days after randomization)
- Lung injury score on day 3 after randomization(3 days after randomization)
- Lung injury score on day 7 after randomization(7 days after randomization)
- ICU length of stay(From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 days)
- Rates of new diagnosis of ARDS according to the new Berlin criteria after randomization(From date of randomization until the date of new onset ARDS diagnosis after randomization or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days)
- Glasgow Outcome Scale (GOS) at hospital discharge(From date of randomization until the date of hospital discharge or date of death from any cause , whichever came first, assessed up to 28 days)
- Hospital length of stay(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days)
- Barotrauma(From date of randomization until the date of first documented barotrauma or date of death from any cause, whichever came first, assessed up to 28 days)
- Cardiac arrhythmia(From date of randomization until the date of first documented cardiac arrhythmia events or date of death from any cause, whichever came first, assessed up to 28 days)
- Serious adverse events(From date of randomization until the date of first documented serious adverse events or date of death from any cause, whichever came first, assessed up to 28 days)
- Maximum infusion dose (per hour) of vasopressor(From date of vasopressor initiation until the date of vasopressor discontinuation or date of death from any cause, whichever came first, assessed up to 28 days)
- Duration (days) of vasopressor(From date of vasopressor initiation until the date of vasopressor discontinuation or date of death from any cause, whichever came first, assessed up to 28 days)
研究者
Natdanai Ketdao
Principal Investigator
Siriraj Hospital