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

Completed · Phase 4

Conditions studied: Acute Respiratory Failure, Intubation Complication, Hypotension on Induction

In brief

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.

Key facts

Study ID

NCT03787732

Run by

Vanderbilt University Medical Center

People needed

1067

Starts

2019-02-01

Expected to finish

2021-06-21

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Louisiana State University School of Medicine — New Orleans, Louisiana, United States
• Ochsner Medical Center | Ochsner Health System — New Orleans, Louisiana, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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