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

Status:	Recruiting
Conditions:	Cardiology, Hospital, Hospital, Pulmonary
Therapuetic Areas:	Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases, Other
Healthy:	No
Age Range:	18 - Any
Updated:	2/28/2019
Start Date:	February 1, 2019
End Date:	September 2021
Contact:	Jonathan D Casey, MD
Email:	Jonathan.d.Casey@vumc.org
Phone:	(615) 208-6139

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

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.

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. The trial will enroll 750 patients. 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

Inclusion Criteria:

1. Patient is undergoing endotracheal intubation in a participating unit

2. Planned operator is a provider expected to routinely perform endotracheal intubation
in the participating unit

3. Patient is at least 18 years of age

4. Administration of sedation is planned (with or without neuromuscular blockade)

5. Positive pressure ventilation between induction and laryngoscopy is planned (e.g.,
non-invasive ventilation or bag-mask ventilation)

Exclusion Criteria:

1. Prisoners

2. Pregnant patients

3. Urgency of intubation precludes safe performance of study procedures

4. Operator feels administration of a fluid bolus is indicated or contraindicated for the
safe performance of the procedure

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000