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Endotracheal intubation is common in the care of critically ill patients. Complications of airway management in this setting are frequently encountered and may be associated with an increased risk of death. The prevention of complications during urgent and emergent endotracheal intubation is a key focus for airway management research. Post-intubation hypotension (PIH), a common complication of endotracheal intubation in the critically ill, may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but this approach has not been examined in a prospective trial. There are no randomized trials of intravenous fluid administration to prevent PIH in critically ill adults. The investigators propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
The investigators propose a randomized, parallel-group trial evaluating the impact of fluid loading to decrease cardiovascular collapse during and after endotracheal intubation in critically ill adults. Patients admitted to the study sites who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be enrolled and randomly assigned to intravenous fluid loading versus none. All other decisions regarding airway management will remain at the discretion of the treating provider. Data will be collected at the time of intubation and prospectively from the medical record in order to determine the effect of the assigned intervention on short- and long-term outcomes. All data are collected non-invasively and are already a part of clinical data obtained in usual ICU care at the bedside or in the medical record. No additional data will be collected that is not observed at the bedside or obtained from the medical record.
Study Population: The study population will be all critically ill adults for whom the clinical team has decided to perform endotracheal intubation using sedation with or without neuromuscular blockade. Patients will be excluded only if the operator feels: 1. Additional intravenous fluids in the form of fluid loading is absolutely indicated or contraindicated, or 2. The urgency of the intubation would make performing the study procedures unsafe. Patients will be included regardless of gender, race, weight or body mass index, initial oxygen saturation, anticipated grade of view, and other clinical factors.
Study Interventions:
Fluid Loading - (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
No Fluid Loading - No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
Primary Endpoint:
Cardiovascular collapse - a composite endpoint defined as one or more of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid Loading | Experimental | (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. |
|
| Usual Care | No Intervention | No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous crystalloid fluid, 500 mL | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiovascular Collapse | a composite endpoint defined as one or more of the following:
| 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Mortality | What was the patient's vital status at the time of hospital discharge | from date of randomization through study completion, an average of 28 days |
| Ventilator-free Days | Number of days alive and free of invasive ventilation in a 28-day period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Janz, MD, MSc | LSU School of Medicine New Orleans | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | United States | |||
| Ochsner Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31585796 | Derived | Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluid Loading | (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. intravenous crystalloid fluid, 500 mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2018 | Dec 8, 2020 |
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| from date of randomization through study completion, an average of 28 days |
| ICU-free Days | Number of days alive and outside of an ICU in a 28 day period | from date of randomization through study completion, an average of 28 days |
| Lowest Arterial Oxygen Saturation | Lowest arterial oxygen saturation between induction and 2 min after intubation | between induction and 2 minutes following procedure |
| Number of Laryngoscopy Attempts | Number of laryngoscopy attempts to achieve successful tracheal intubation | during procedure |
| Lowest Systolic Blood Pressure | Lowest systolic blood pressure between induction and 2 min after intubation | between induction and 2 minutes following procedure |
| Jefferson |
| Louisiana |
| 70121 |
| United States |
| LSUHSC and University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Lahey Medical Center | Burlington | Massachusetts | 01805 | United States |
| Lincoln Medical Center | The Bronx | New York | 10451 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| FG001 | Usual Care | No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. |
| COMPLETED |
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| NOT COMPLETED |
|
All patients randomized were included in the baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluid Loading | (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. intravenous crystalloid fluid, 500 mL |
| BG001 | Usual Care | No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body-mass index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Acute physiology and chronic health evaluation score | range 0 to 71, higher scores indicate a higher severity of illness | Median | Inter-Quartile Range | units on a scale, range 0 to 71 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cardiovascular Collapse | a composite endpoint defined as one or more of the following:
| All patients randomized were included in the primary analysis | Posted | Count of Participants | Participants | 1 hour |
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| Secondary | In-hospital Mortality | What was the patient's vital status at the time of hospital discharge | intention to treat | Posted | Count of Participants | Participants | from date of randomization through study completion, an average of 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Ventilator-free Days | Number of days alive and free of invasive ventilation in a 28-day period | intention to treat | Posted | Median | Inter-Quartile Range | days | from date of randomization through study completion, an average of 28 days |
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| |||||||||||||||||||||||||||||
| Secondary | ICU-free Days | Number of days alive and outside of an ICU in a 28 day period | intention to treat | Posted | Median | Inter-Quartile Range | days | from date of randomization through study completion, an average of 28 days |
|
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| Secondary | Lowest Arterial Oxygen Saturation | Lowest arterial oxygen saturation between induction and 2 min after intubation | intention to treat | Posted | Median | Inter-Quartile Range | percentage of hemoglobin | between induction and 2 minutes following procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Laryngoscopy Attempts | Number of laryngoscopy attempts to achieve successful tracheal intubation | intention to treat | Posted | Median | Inter-Quartile Range | attempts | during procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | Lowest Systolic Blood Pressure | Lowest systolic blood pressure between induction and 2 min after intubation | intention to treat | Posted | Median | Inter-Quartile Range | mmHg | between induction and 2 minutes following procedure |
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28 days after enrollment and randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluid Loading | (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. intravenous crystalloid fluid, 500 mL | 48 | 168 | 0 | 168 | 0 | 168 |
| EG001 | Usual Care | No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered. | 59 | 169 | 0 | 169 | 0 | 169 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Janz | LSUHSC New Orleans | 504-913-5006 | djanz@lsuhsc.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 8, 2020 | Dec 8, 2020 | Prot_001.pdf |
| Male |
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| Other |
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