Effect of a FLUid Bolus or a Low Dose VAsopressor Infusion on Cardiovascular Collapse Among Critically Ill Adults Undergoing Tracheal Intubation: a Randomized Controlled Trial (FLUVA Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cardiovascular collapse (composite outcome)
研究概览
简要总结
Tracheal intubation, which is one of the most commonly performed procedures in the care of critically ill patients in intensive care unit, is associated with a high incidence of complications. Approximately 30% of emergent tracheal intubations in the ICU are associated with complications like hypotension, hypoxia, failed tracheal intubation, esophageal intubation, airway trauma, aspiration, cardiac arrest, and death. An observational study of tracheal intubation practices in critically ill patients across twenty-nine countries found cardiovascular instability to be the commonest among these adverse peri-tracheal intubation event.
Tracheal intubation performed in a controlled, non-emergent setting, is associated with few complications. However in ICU, conditions like underlying shock, respiratory failure, metabolic acidosis, and other patho-physiological changes contribute to the increased peri-tracheal intubation complications. Post tracheal intubation hypotension frequently occurs within a few minutes following tracheal intubation. The additive effects of hypovolemia, the suppression of the endogenous activation of sympathetic response by the anesthetics drugs as well as the intrathoracic positive pressure due to mechanical ventilation are implicated in this cardiovascular collapse after tracheal intubation in critically ill patients.
Post-tracheal intubation hypotension has been shown to be associated with higher in-hospital mortality and longer ICU and hospital length of stay. Hence patient optimization prior to tracheal intubation may be important to ensure hemodynamic stability to minimize further deterioration during tracheal intubation.
Few techniques to optimize hemodynamics before tracheal intubation commonly involve the use of intravenous fluids and vasopressor medications; however, there are no standards of care guiding these practices. Jaber et al included pre tracheal intubation fluid loading (isotonic saline 500 ml or starch 250 ml) as a part of tracheal intubation care bundle management to show improved outcomes. However it was an observational study and also it was not possible to evaluate the contribution of the individual hemodynamic components of the bundle given the concurrent implementation of other interventions.
And a recent study by Janz et al showed that pre loading with a 500-mL bolus of crystalloids before tracheal intubation did not identify any benefit. However this trial was stopped early for futility and moreover the volume of intravenous fluids that patients received before enrolment was not recorded.
Few trials have used vasopressor bolus prior to tracheal intubation to avoid post tracheal intubation hypotension or use of prophylactic use of vasopressors in preventing post spinal hypotension. However currently, there are no randomized trials or evidence-based guidelines to support the choice between fluid loading or vasopressors for the tracheal intubation of critically ill adults. We would like to conduct a randomised controlled study comparing the effects of fluid bolus or low dose vasopressor given prior to tracheal intubation on post tracheal intubation hypotension among critically ill adults.
详细描述
OBJECTIVES:
Primary Objective:
Cardiovascular collapse - a composite endpoint defined as one or more of the following:
Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg between induction and 5 min after tracheal intubation Cardiac arrest between induction and 1 hour after tracheal intubation; Death between induction and 1 hour after tracheal intubation
Secondary outcomes:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding Preparation for tracheal intubation will be done as per the ICU protocol * The airway operator will be blinded to the intervention and thus sent out of the patient's cubicle. The study team will administer a fluid bolus over 10 minutes. in the FL arm. No fluid will be administered in the VP arm. The fluid bag will be brought into the cubicle in a concealed bag. After fluid administration or not the fluid bag will be taken out in the same bag. A vasopressin infusion or saline infusion will be started at as per the assigned arm at the same time as the fluid bolus. The airway operator will enter the room and proceed with tracheal intubation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years old)
- •Critically ill patients needing emergent tracheal intubation in ICU
排除标准
- •Tracheal intubation performed in the out-of-ICU/hospital setting
- •Tracheal intubation during cardiac arrest.
- •Patients with age <18 years
- •Elective tracheal intubation(for e.g for diagnostic/surgical procedures)
- •Patients on vasoactive medications at the time of screening
- •Hypotension (SBP <90) at screening
- •Hypertension(SBP >140)at screening
- •Urgency of tracheal intubation precludes performance of study procedures
- •Operator feels administration of a fluid bolus vasopressor is strongly indicated or contraindicated
- •Inability to obtain consent from the surrogate
研究组 & 干预措施
Arm Fluids (FL)
500 mL of ringer lactate over 10 minute prior to the administration of procedural medications.
干预措施: Ringer Lactate and Norepinephrine infusion (Drug)
Arm Vasopressor (VP)
Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation.
干预措施: Ringer Lactate and Norepinephrine infusion (Drug)
结局指标
主要结局
Cardiovascular collapse (composite outcome)
时间窗: 1 hour
Cardiovascular collapse - a composite endpoint defined as one or more of the following: Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg between induction and 5 min after tracheal intubation. Cardiac arrest between induction and 1 hour after tracheal intubation. Death between induction and 1 hour after tracheal intubation.
次要结局
- ICU-free days to 28 days(28 days)
- Lowest Systolic Blood Pressure(5 min)
- Hypotension(28 days)
- Vasopressor free days at 28 days(28 days)
- Lowest arterial oxygen saturation(5 min)
- FiO2 at 24 hours(24 hours)
- Cardiac arrest(1 hour)
- Need for Renal Replacement therapy post intubation in ICU(28 days)
- Time from induction to successful tracheal intubation(5 min)
- Cormack-Lehane grade of glottic view on first attempt(5 min)
- Ventilator-free days to 28 days(28 days)
- Severe Hypoxemia(5 min)
- Oxygen Saturation at 24 hours(24 hours)
- Initiation of an intravenous fluid bolus(5 min)
- Death(1 hour)
- 28 days Mortality(28 days)
- Incidence of hypertension(5 min)
- Need for vasopressors(5 min)
- Number of laryngoscopy attempts(5 min)
- ICU Mortality(No of days stayed in the ICU)
- Hospital Mortality(No of days stayed in the Hospital)
- Hypoxemia(5 min)
- Pao2 /FiO2 ratio at 24 hours(24 hours)
- Incidence of successful tracheal intubation on the first laryngoscopy attempt(5 min)
- Need for additional airway equipment or a second operator(5 min)