Status:
COMPLETED
Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Acute Respiratory Failure
Intubation Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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, define...
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 cardiovascula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
1067 Patients enrolled
Trial Details
Trial ID
NCT03787732
Start Date
February 1 2019
End Date
June 21 2021
Last Update
August 12 2021
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112
3
Ochsner Medical Center | Ochsner Health System
New Orleans, Louisiana, United States, 70121
4
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805