Acute Respiratory Failure Clinical Trial
— PREPARE IIOfficial title:
Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)
Verified date | August 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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 |
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