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

NCT03787732 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1067

Last updated 2021-08-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • David R Janz, MD, MSCI · Louisiana State University Health Sciences Center in New Orleans

  • Derek W Russell, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-05-24
Completion
2021-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787732 on ClinicalTrials.gov