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

Acute Respiratory Failure Clinical Trial

— PREPARE II  

Official title:

Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787732
• Other study ID #: IRB# 181690
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: August 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1067
• Est. completion date: June 21, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Hypotension
• Hypotension on Induction
• Intubation Complication
• Respiratory Insufficiency
• Shock

Intervention

Drug:
• Fluid Bolus
500 milliliters of an intravenous crystalloid solution of the operator's choosing

Other:
• No Fluid Bolus
No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
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	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Ochsner Medical Center | Ochsner Health System	New Orleans	Louisiana
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Washington	Seattle	Washington
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation		from induction to 2 minutes following tracheal intubation
Other	New or increased vasopressor between induction and 2 minutes after intubation		from induction to 2 minutes following tracheal intubation
Other	Cardiac arrest within 1 hour of intubation		1 hour
Other	Death within 1 hour of intubation		1 hour
Other	Lowest systolic blood pressure between induction and 2 minutes after intubation		from induction to 2 minutes following tracheal intubation
Other	Change in systolic blood pressure from induction to lowest systolic blood pressure		between induction and 2 minutes following procedure
Other	Ventilator-free days		28 days
Other	ICU-free days		28 days
Other	Lowest oxygen saturation	Lowest arterial oxygen saturation between induction and 2 minutes after intubation	from induction to 2 minutes following tracheal intubation
Other	Incidence of hypoxemia	Incidence of oxygen saturation < 90% between induction and 2 minutes after intubation	from induction to 2 minutes following tracheal intubation
Other	Incidence of severe hypoxemia	Incidence of oxygen saturation < 80% between induction and 2 minutes after intubation	from induction to 2 minutes following tracheal intubation
Other	Oxygen saturation at 24 hours after intubation		24 hours
Other	Fraction of inspired oxygen at 24 hours after intubation		24 hours
Other	Positive end expiratory pressure at 24 hours after intubation		24 hours
Other	Systolic blood pressure at 24 hours after intubation		24 hours
Other	Additional intravenous fluids initiated between induction and 2 minutes after intubation		from induction to 2 minutes following tracheal intubation
Other	Time from induction to successful intubation		Duration of procedure (minutes)
Other	Cormack-Lehane grade of glottic view on first attempt		Duration of procedure (minutes)
Other	Difficulty of intubation	Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult.	Duration of procedure (minutes)
Other	Incidence of successful intubation on the first laryngoscopy attempt		Duration of procedure (minutes)
Other	Number of laryngoscopy attempts		Duration of procedure (minutes)
Other	Need for additional airway equipment or a second operator		Duration of procedure (minutes)
Primary	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	28-day in-hospital mortality		28 days