Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 6
- 主要终点
- Number of patients with cardiovascular collapse
研究概览
简要总结
Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.
详细描述
PREVENTION trial is a pragmatic, multi-center, un-blinded, parallel group, randomized study comparing the pre-emptive use of noradrenaline to no-vasopressors during the peri-intubation period of adult critically ill patients. Investigators hypothesize that the pre-emptive administration of noradrenaline would mitigate the incidence and severity of peri-intubation cardiovascular collapse. The study will include adult (18 yrs or older) critically ill patients needing in-hospital intubation, excluding patients with absolute indication or contraindication to vasopressors. Patients will be randomized to receive either a continuous infusion of noradrenaline started at least 8 minutes before induction vs no vasopressors during the peri-intubation period. All co-interventions will be provided according to clinician's judgement. The primary outcome of the study will be a composite of MAP < 60 mmHg or cardiac arrest. Secondary outcomes will include lowest systolic blood pressure < 30 minutes from induction, change in systolic blood pressure from baseline to the lowest value within 30 minutes from induction and cardiac arrest.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is admitted or scheduled for admission to a participating study hospital
- •Planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- •Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment)
- •Administration of sedation (with or without neuromuscular blockade) is planned
- •Age 18 years or older
排除标准
- •No vasopressors/inotropes at the moment of screening for eligibility
- •MAP < 60 mmHg or > 120 mmHg at the moment of screening for eligibility
- •Urgency of intubation precludes safe performance of study procedures
- •Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest
- •Enrolled in another clinical trial that is unapproved for co-enrollment
- •Pregnant or suspected pregnancy
研究组 & 干预措施
Pre-emptive vasopressor
Pre-emptive continuous infusion of norepinephrine during intubation
干预措施: Noradrenaline (Drug)
结局指标
主要结局
Number of patients with cardiovascular collapse
时间窗: 30 minutes from induction
Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest
次要结局
- Change in SBP value from last value before induction to lowest value(30 minutes from induction)
- Lowest value of SBP(30 minutes from induction)
- Need for a rescue vasopressor(30 minutes from induction)
- Number of patients with MAP < 60 mmHg(30 minutes from induction)
- Number of patients with severe hypertension(30 minutes from induction)
- Number of patients with cardiac arrest(30 minutes from induction)
研究者
Vincenzo Russotto
Principal Investigator
University of Turin, Italy