Clinical trial NCT03787732: Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation
Official title: Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Respiratory Failure
Intubation Complication
Hypotension on Induction
Keywords: Intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 1067
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: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular collapse
timeFrame: 1 hour
Secondary outcomes:
measure: 28-day in-hospital mortality
timeFrame: 28 days
Other outcomes:
measure: New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: New or increased vasopressor between induction and 2 minutes after intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Cardiac arrest within 1 hour of intubation
timeFrame: 1 hour
measure: Death within 1 hour of intubation
timeFrame: 1 hour
measure: Lowest systolic blood pressure between induction and 2 minutes after intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Change in systolic blood pressure from induction to lowest systolic blood pressure
timeFrame: between induction and 2 minutes following procedure
measure: Ventilator-free days
timeFrame: 28 days
measure: ICU-free days
timeFrame: 28 days
measure: Lowest oxygen saturation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Incidence of hypoxemia
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Incidence of severe hypoxemia
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Oxygen saturation at 24 hours after intubation
timeFrame: 24 hours
measure: Fraction of inspired oxygen at 24 hours after intubation
timeFrame: 24 hours
measure: Positive end expiratory pressure at 24 hours after intubation
timeFrame: 24 hours
measure: Systolic blood pressure at 24 hours after intubation
timeFrame: 24 hours
measure: Additional intravenous fluids initiated between induction and 2 minutes after intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Time from induction to successful intubation
timeFrame: Duration of procedure (minutes)
measure: Cormack-Lehane grade of glottic view on first attempt
timeFrame: Duration of procedure (minutes)
measure: Difficulty of intubation
timeFrame: Duration of procedure (minutes)
measure: Incidence of successful intubation on the first laryngoscopy attempt
timeFrame: Duration of procedure (minutes)
measure: Number of laryngoscopy attempts
timeFrame: Duration of procedure (minutes)
measure: Need for additional airway equipment or a second operator
timeFrame: Duration of procedure (minutes)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center | Ochsner Health System
state: Louisiana
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: David R Janz, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Derek W Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russell DW, Casey JD, Gibbs KW, Ghamande S, Dargin JM, Vonderhaar DJ, Joffe AM, Khan A, Prekker ME, Brewer JM, Dutta S, Landsperger JS, White HD, Robison SW, Wozniak JM, Stempek S, Barnes CR, Krol OF, Arroliga AC, Lat T, Gandotra S, Gulati S, Bentov I, Walters AM, Dischert KM, Nonas S, Driver BE, Wang L, Lindsell CJ, Self WH, Rice TW, Janz DR, Semler MW; PREPARE II Investigators and the Pragmatic Critical Care Research Group. Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):270-279. doi: 10.1001/jama.2022.9792.
citation: Russell DW, Casey JD, Gibbs KW, Dargin JM, Vonderhaar DJ, Joffe AM, Ghamande S, Khan A, Dutta S, Landsperger JS, Robison SW, Bentov I, Wozniak JM, Stempek S, White HD, Krol OF, Prekker ME, Driver BE, Brewer JM, Wang L, Lindsell CJ, Self WH, Rice TW, Semler MW, Janz D; PREPARE II Investigators. Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial. BMJ Open. 2020 Sep 18;10(9):e036671. doi: 10.1136/bmjopen-2019-036671.