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

NCT03787732 | Completed Phase 4 DMC

• 1 other identifier: IRB# 181690
• Study Type: interventional
• Target: 1,067
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Respiratory Failure; Intubation Complication; Hypotension on Induction

Keywords

Intubation

Outcome Measures

Primary Outcomes (1)

• Cardiovascular collapse

  A composite endpoint defined as one or more of the following * New systolic blood pressure \< 65 mmHg between induction and 2 minutes after intubation * New or increased vasopressor between induction and 2 minutes after intubation * Cardiac arrest within 1 hour of intubation * Death within 1 hour of intubation

  1 hour

Secondary Outcomes (1)

• 28-day in-hospital mortality

  28 days

Other Outcomes (22)

• New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation

  from induction to 2 minutes following tracheal intubation

• New or increased vasopressor between induction and 2 minutes after intubation

  from induction to 2 minutes following tracheal intubation

• Cardiac arrest within 1 hour of intubation

  1 hour

Study Arms (2)

Fluid Bolus

ACTIVE COMPARATOR

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.

Drug: Fluid Bolus

No Fluid Bolus

ACTIVE COMPARATOR

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).

Other: No Fluid Bolus

Interventions

Fluid Bolus DRUG

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

Also known as: intravenous crystalloid fluid, 500 mL

Fluid Bolus

No Fluid Bolus OTHER

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

No Fluid Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing endotracheal intubation in a participating unit
• Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
• Patient is at least 18 years of age
• Administration of sedation is planned (with or without neuromuscular blockade)
• Positive pressure ventilation between induction and laryngoscopy is planned (e.g., non-invasive ventilation or bag-mask ventilation)

You may not qualify if:

• Prisoners
• Pregnant patients
• Urgency of intubation precludes safe performance of study procedures
• Operator feels administration of a fluid bolus is indicated or contraindicated for the safe performance of the procedure

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Location

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 35707974 DERIVED

• 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.

  PMID: 32948554 DERIVED

Study Officials

• David R Janz, MD, MSCI

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

• Derek W Russell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: December 26, 2018
• Study Start: February 1, 2019
• Primary Completion: May 24, 2021
• Study Completion: June 21, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (11)