Clinical trial NCT03026777: Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation
Official title: Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Respiratory Failure
Intubation Complication
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Primary Endpoint:

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Cardiovascular Collapse
timeFrame: 1 hour
Secondary outcomes:
measure: In-hospital Mortality
timeFrame: from date of randomization through study completion, an average of 28 days
measure: Ventilator-free Days
timeFrame: from date of randomization through study completion, an average of 28 days
measure: ICU-free Days
timeFrame: from date of randomization through study completion, an average of 28 days
measure: Lowest Arterial Oxygen Saturation
timeFrame: between induction and 2 minutes following procedure
measure: Number of Laryngoscopy Attempts
timeFrame: during procedure
measure: Lowest Systolic Blood Pressure
timeFrame: between induction and 2 minutes following procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Jefferson
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: LSUHSC and University Medical Center
state: Louisiana
city: Burlington
country: United States
facility: Lahey Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: LSU School of Medicine New Orleans
name: David Janz, MD, MSc
role: STUDY_CHAIR
References:
citation: Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.