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Completed

NCT Number: NCT03787732

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

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.

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Key information

Conditions

Acute Respiratory Failure Hypotension on Induction Intubation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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:

  • 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

The secondary outcome is 28-day in-hospital mortality

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Fluid bolus

Drug

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

Other names: intravenous crystalloid fluid, 500 mL

No Fluid Bolus

Other

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

Primary outcomes

  1. Cardiovascular collapse

    Time frame: 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 outcomes

  1. 28-day in-hospital mortality

    Time frame: 28 days

Other outcomes

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

    Time frame: from induction to 2 minutes following tracheal intubation

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

    Time frame: from induction to 2 minutes following tracheal intubation

  3. Cardiac arrest within 1 hour of intubation

    Time frame: 1 hour

  4. Death within 1 hour of intubation

    Time frame: 1 hour

  5. Lowest systolic blood pressure between induction and 2 minutes after intubation

    Time frame: from induction to 2 minutes following tracheal intubation

  6. Change in systolic blood pressure from induction to lowest systolic blood pressure

    Time frame: between induction and 2 minutes following procedure

  7. Ventilator-free days

    Time frame: 28 days

  8. ICU-free days

    Time frame: 28 days

  9. Lowest oxygen saturation

    Time frame: from induction to 2 minutes following tracheal intubation

    Lowest arterial oxygen saturation between induction and 2 minutes after intubation

  10. Incidence of hypoxemia

    Time frame: from induction to 2 minutes following tracheal intubation

    Incidence of oxygen saturation < 90% between induction and 2 minutes after intubation

  11. Incidence of severe hypoxemia

    Time frame: from induction to 2 minutes following tracheal intubation

    Incidence of oxygen saturation < 80% between induction and 2 minutes after intubation

  12. Oxygen saturation at 24 hours after intubation

    Time frame: 24 hours

  13. Fraction of inspired oxygen at 24 hours after intubation

    Time frame: 24 hours

  14. Positive end expiratory pressure at 24 hours after intubation

    Time frame: 24 hours

  15. Systolic blood pressure at 24 hours after intubation

    Time frame: 24 hours

  16. Additional intravenous fluids initiated between induction and 2 minutes after intubation

    Time frame: from induction to 2 minutes following tracheal intubation

  17. Time from induction to successful intubation

    Time frame: Duration of procedure (minutes)

  18. Cormack-Lehane grade of glottic view on first attempt

    Time frame: Duration of procedure (minutes)

  19. Difficulty of intubation

    Time frame: Duration of procedure (minutes)

    Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult.

  20. Incidence of successful intubation on the first laryngoscopy attempt

    Time frame: Duration of procedure (minutes)

  21. Number of laryngoscopy attempts

    Time frame: Duration of procedure (minutes)

  22. Need for additional airway equipment or a second operator

    Time frame: Duration of procedure (minutes)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Acronym: PREPARE II

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2018
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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