Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation (PrePARE)

Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Acute Respiratory Failure
• Intervention / Treatment: Drug: intravenous crystalloid fluid, 500 mL

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

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • University of Alabama Birmingham
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Ochsner Medical Center
    • New Orleans, Louisiana, United States, 70112
      • LSUHSC and University Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Medical Center
  • New York
    • Bronx, New York, United States, 10451
      • Lincoln Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: intravenous crystalloid fluid, 500 mL
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 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	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Mortality	What was the patient's vital status at the time of hospital discharge	from date of randomization through study completion, an average of 28 days
Ventilator-free Days	Number of days alive and free of invasive ventilation in a 28-day period	from date of randomization through study completion, an average of 28 days
ICU-free Days	Number of days alive and outside of an ICU in a 28 day period	from date of randomization through study completion, an average of 28 days
Lowest Arterial Oxygen Saturation	Lowest arterial oxygen saturation between induction and 2 min after intubation	between induction and 2 minutes following procedure
Number of Laryngoscopy Attempts	Number of laryngoscopy attempts to achieve successful tracheal intubation	during procedure
Lowest Systolic Blood Pressure	Lowest systolic blood pressure between induction and 2 min after intubation	between induction and 2 minutes following procedure

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Study Chair: David Janz, MD, MSc, LSU School of Medicine New Orleans

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Shock
• Other Study ID Numbers: PREPARE