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:
1. Death within 1 hour of intubation
2. Cardiac arrest within 1 hour of intubation
3. New systolic blood pressure \< 65 mmHg between induction and 2 minutes after completion of intubation
4. New or increased vasopressor receipt between induction and 2 minutes after completion of intubation
The secondary outcome is 28-day in-hospital mortality
