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

NCT ID: NCT03787732

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1067 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-06-21

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

Conditions

Acute Respiratory Failure; Intubation Complication; Hypotension on Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluid Bolus

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.

Group Type: ACTIVE_COMPARATOR

Fluid Bolus

Intervention Type: DRUG

500 milliliters of an intravenous crystalloid solution of the operator's choosing

No Fluid Bolus

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).

Group Type: ACTIVE_COMPARATOR

No Fluid Bolus

Intervention Type: OTHER

No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation

Interventions

Fluid Bolus

500 milliliters of an intravenous crystalloid solution of the operator's choosing

Intervention Type: DRUG

No Fluid Bolus

No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation

Intervention Type: OTHER

Other Intervention Names

intravenous crystalloid fluid, 500 mL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Matthew Semler

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Janz, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Derek W Russell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Louisiana State University School of Medicine

New Orleans, Louisiana, United States

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Scott & White Medical Center - Temple

Temple, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35707974 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32948554 (View on PubMed)

Other Identifiers

IRB# 181690

Identifier Type: -

Identifier Source: org_study_id