Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 7
- 主要终点
- Number of Participants With Cardiovascular Collapse
研究概览
简要总结
Endotracheal intubation is common in the care of critically ill patients. Complications of airway management in this setting are frequently encountered and may be associated with an increased risk of death. The prevention of complications during urgent and emergent endotracheal intubation is a key focus for airway management research. Post-intubation hypotension (PIH), a common complication of endotracheal intubation in the critically ill, may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but this approach has not been examined in a prospective trial. There are no randomized trials of intravenous fluid administration to prevent PIH in critically ill adults. The investigators propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
详细描述
The investigators propose a randomized, parallel-group trial evaluating the impact of fluid loading to decrease cardiovascular collapse during and after endotracheal intubation in critically ill adults. Patients admitted to the study sites who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be enrolled and randomly assigned to intravenous fluid loading versus none. All other decisions regarding airway management will remain at the discretion of the treating provider. Data will be collected at the time of intubation and prospectively from the medical record in order to determine the effect of the assigned intervention on short- and long-term outcomes. All data are collected non-invasively and are already a part of clinical data obtained in usual ICU care at the bedside or in the medical record. No additional data will be collected that is not observed at the bedside or obtained from the medical record.
Study Population: The study population will be all critically ill adults for whom the clinical team has decided to perform endotracheal intubation using sedation with or without neuromuscular blockade. Patients will be excluded only if the operator feels: 1. Additional intravenous fluids in the form of fluid loading is absolutely indicated or contraindicated, or 2. The urgency of the intubation would make performing the study procedures unsafe. Patients will be included regardless of gender, race, weight or body mass index, initial oxygen saturation, anticipated grade of view, and other clinical factors.
Study Interventions:
Fluid Loading - (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
No Fluid Loading - No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient is admitted to participating study unit
- •Planned procedure is endotracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- •Administration of sedation with or without neuromuscular blockade is planned
- •Age ≥ 18 years old
排除标准
- •Operator believes fluid loading to be absolutely indicated or contraindicated for the safe care of the patient
- •Urgency of intubation precludes safe performance of study procedures
- •Pregnancy
- •Prisoners
- •Age < 18 years old
研究组 & 干预措施
Fluid Loading
(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
干预措施: intravenous crystalloid fluid, 500 mL (Drug)
结局指标
主要结局
Number of Participants With Cardiovascular Collapse
时间窗: 1 hour
a composite endpoint defined as one or more of the following: * Death within 1 hour of intubation * Cardiac arrest within 1 hour of intubation * New systolic blood pressure \< 65 mmHg between induction and 2 minutes after completion of intubation * New or increased vasopressor receipt between induction and 2 minutes after completion of intubation
次要结局
- In-hospital Mortality(from date of randomization through study completion, an average of 28 days)
- Ventilator-free Days(from date of randomization through study completion, an average of 28 days)
- ICU-free Days(from date of randomization through study completion, an average of 28 days)
- Lowest Arterial Oxygen Saturation(between induction and 2 minutes following procedure)
- Number of Laryngoscopy Attempts(during procedure)
- Lowest Systolic Blood Pressure(between induction and 2 minutes following procedure)
研究者
David Janz
Assistant Professor of Medicine
Louisiana State University Health Sciences Center in New Orleans