Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation

Study Overview
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Brief Summary
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Complications are common during tracheal intubation of critically ill patients. Nearly one in five patients undergoing intubation in the intensive care unit experiences cardiovascular collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death. Cardiovascular collapse during intubation is associated with increased resource utilization and decreased survival. Administration of 500 mL of intravenous crystalloid solution beginning prior to induction may prevent cardiovascular collapse. The only prior trial examining fluid bolus administration during intubation found no effect on cardiovascular collapse or clinical outcomes overall, but a hypothesis-generating subgroup analysis suggested potential benefit to fluid bolus administration among patients receiving positive pressure ventilation between induction and laryngoscopy. Therefore, we propose a randomized trial comparing fluid bolus administration versus none with regard to cardiovascular collapse among critically adults undergoing intubation with positive pressure ventilation between induction and laryngoscopy.

Detailed Description
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The PREPARE II trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of a preintubation fluid bolus to no preintubation fluid bolus on the incidence of cardiovascular collapse during and after endotracheal intubation in critically ill adults. Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to receive either an intravenous fluid bolus or no intravenous fluid bolus. All other decisions regarding airway management will remain at the discretion of the treating provider. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 375 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment. The primary outcome is cardiovascular collapse - 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 The secondary outcome is 28-day in-hospital mortality

Official Title
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Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)

Conditions
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Acute Respiratory Failure, Intubation Complication, Hypotension on Induction

Intervention / Treatment
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* Drug: Fluid Bolus
* Other: No Fluid Bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing endotracheal intubation in a participating unit Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit Patient is at least 18 years of age Administration of sedation is planned (with or without neuromuscular blockade) Positive pressure ventilation between induction and laryngoscopy is planned (e.g., non-invasive ventilation or bag-mask ventilation) Exclusion Criteria: Prisoners Pregnant patients Urgency of intubation precludes safe performance of study procedures Operator feels administration of a fluid bolus is indicated or contraindicated for the safe performance of the procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluid Bolus<br>For patients randomized to fluid bolus administration, the bedside nurse will obtain 500 mL of a crystalloid solution of the operator's choosing, connect this volume to intravenous infusion tubing, and attach the tubing to any intravenous catheter or intraosseous device. The crystalloid solution will then be placed above the level of the intravenous or intraosseous device and allowed to infuse by gravity or pressure bag. At any time after the initiation of fluid bolus administration, the operator can choose to begin the procedure by administering sedation. Fluid loading will continue until all 500 mL are infused. Fluid infusing prior to the decision to perform endotracheal intubation will not be altered by the current study. | Drug: Fluid Bolus<br>* 500 milliliters of an intravenous crystalloid solution of the operator's choosing<br>* Other names: intravenous crystalloid fluid, 500 mL;|
| Active Comparator: No Fluid Bolus<br>For patients randomized to no fluid bolus administration, no additional intravenous crystalloid administration will be initiated between randomization and two minutes after completion of endotracheal intubation. Fluid infusing prior to the decision to perform endotracheal intubation will not be affected by the study. Treating clinicians may initiate a fluid bolus at any time for the treatment of cardiovascular collapse (not considered a protocol violation). Treating clinicians may also initiate a fluid bolus at any time if felt to be mandatory for the safe treatment of the patient (if between randomization and two minutes after intubation and in the absence of cardiovascular collapse this will be recorded as a protocol violation). | Other: No Fluid Bolus<br>* No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular collapse | A composite endpoint defined as one or more of the following New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation New or increased vasopressor between induction and 2 minutes after intubation Cardiac arrest within 1 hour of intubation Death within 1 hour of intubation | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day in-hospital mortality |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation