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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.
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:
The secondary outcome is 28-day in-hospital mortality
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid Bolus | Active Comparator | For patients randomized to fluid bolus administration, the bedside nurse will obtain 500 mL of a crystalloid solution of the operator's choosing, connect this volume to intravenous infusion tubing, and attach the tubing to any intravenous catheter or intraosseous device. The crystalloid solution will then be placed above the level of the intravenous or intraosseous device and allowed to infuse by gravity or pressure bag. At any time after the initiation of fluid bolus administration, the operator can choose to begin the procedure by administering sedation. Fluid loading will continue until all 500 mL are infused. Fluid infusing prior to the decision to perform endotracheal intubation will not be altered by the current study. |
|
| No Fluid Bolus | Active Comparator | For patients randomized to no fluid bolus administration, no additional intravenous crystalloid administration will be initiated between randomization and two minutes after completion of endotracheal intubation. Fluid infusing prior to the decision to perform endotracheal intubation will not be affected by the study. Treating clinicians may initiate a fluid bolus at any time for the treatment of cardiovascular collapse (not considered a protocol violation). Treating clinicians may also initiate a fluid bolus at any time if felt to be mandatory for the safe treatment of the patient (if between randomization and two minutes after intubation and in the absence of cardiovascular collapse this will be recorded as a protocol violation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid Bolus | Drug | 500 milliliters of an intravenous crystalloid solution of the operator's choosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular collapse | A composite endpoint defined as one or more of the following
| 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day in-hospital mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation | |
| New or increased vasopressor between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Janz, MD, MSCI | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Derek W Russell, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Louisiana State University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35707974 | Derived | Russell DW, Casey JD, Gibbs KW, Ghamande S, Dargin JM, Vonderhaar DJ, Joffe AM, Khan A, Prekker ME, Brewer JM, Dutta S, Landsperger JS, White HD, Robison SW, Wozniak JM, Stempek S, Barnes CR, Krol OF, Arroliga AC, Lat T, Gandotra S, Gulati S, Bentov I, Walters AM, Dischert KM, Nonas S, Driver BE, Wang L, Lindsell CJ, Self WH, Rice TW, Janz DR, Semler MW; PREPARE II Investigators and the Pragmatic Critical Care Research Group. Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):270-279. doi: 10.1001/jama.2022.9792. | |
| 32948554 |
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| No Fluid Bolus | Other | No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation |
|
| Cardiac arrest within 1 hour of intubation | 1 hour |
| Death within 1 hour of intubation | 1 hour |
| Lowest systolic blood pressure between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Change in systolic blood pressure from induction to lowest systolic blood pressure | between induction and 2 minutes following procedure |
| Ventilator-free days | 28 days |
| ICU-free days | 28 days |
| Lowest oxygen saturation | Lowest arterial oxygen saturation between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Incidence of hypoxemia | Incidence of oxygen saturation < 90% between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Incidence of severe hypoxemia | Incidence of oxygen saturation < 80% between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Oxygen saturation at 24 hours after intubation | 24 hours |
| Fraction of inspired oxygen at 24 hours after intubation | 24 hours |
| Positive end expiratory pressure at 24 hours after intubation | 24 hours |
| Systolic blood pressure at 24 hours after intubation | 24 hours |
| Additional intravenous fluids initiated between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Time from induction to successful intubation | Duration of procedure (minutes) |
| Cormack-Lehane grade of glottic view on first attempt | Duration of procedure (minutes) |
| Difficulty of intubation | Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult. | Duration of procedure (minutes) |
| Incidence of successful intubation on the first laryngoscopy attempt | Duration of procedure (minutes) |
| Number of laryngoscopy attempts | Duration of procedure (minutes) |
| Need for additional airway equipment or a second operator | Duration of procedure (minutes) |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Ochsner Medical Center | Ochsner Health System | New Orleans | Louisiana | 70121 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37209 | United States |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Derived |
| Russell DW, Casey JD, Gibbs KW, Dargin JM, Vonderhaar DJ, Joffe AM, Ghamande S, Khan A, Dutta S, Landsperger JS, Robison SW, Bentov I, Wozniak JM, Stempek S, White HD, Krol OF, Prekker ME, Driver BE, Brewer JM, Wang L, Lindsell CJ, Self WH, Rice TW, Semler MW, Janz D; PREPARE II Investigators. Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial. BMJ Open. 2020 Sep 18;10(9):e036671. doi: 10.1136/bmjopen-2019-036671. |