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

Phase 4

Completed

• Conditions: Intubation Complication; Acute Respiratory Failure; Hypotension on Induction
• Interventions: Drug: Fluid Bolus; Other: No Fluid Bolus

• Registration Number: NCT03787732
• Lead Sponsor: Vanderbilt University Medical Center

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-22
• Study First Submitted QC: 2018-12-22
• Study First Posted: 2018-12-26
• Study Start: 2019-02-01
• Primary Completion: 2021-05-24
• Study Completion: 2021-06-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1067

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid Bolus	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.
No Fluid Bolus	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).

Primary Outcome Measures

Name	Time	Method
Cardiovascular collapse	1 hour	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

Secondary Outcome Measures

Name	Time	Method
28-day in-hospital mortality	28 days

Trial Locations

Locations (11)

Louisiana State University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Ochsner Medical Center | Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States

Baylor Scott & White Medical Center - Temple; 🇺🇸 Temple, Texas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Washington; 🇺🇸 Seattle, Washington, United States