A Phase 4 interventional study of intravenous crystalloid fluid, 500 mL in Acute Respiratory Failure and Intubation Complication, sponsored by Louisiana State University Health Sciences Center in New Orleans. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 4, Interventional, and Prevention
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:
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 337 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(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.
Drug: intravenous crystalloid fluid, 500 mL
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.
Number of Participants With Cardiovascular Collapse
a composite endpoint defined as one or more of the following: * Death within 1 hour of intubation * Cardiac arrest within 1 hour of intubation * New systolic blood pressure \< 65 mmHg between induction and 2 minutes after completion of intubation * New or increased vasopressor receipt between induction and 2 minutes after completion of intubation
Time frame: 1 hour
In-hospital Mortality
What was the patient's vital status at the time of hospital discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: between induction and 2 minutes following procedure
Number of Laryngoscopy Attempts
Number of laryngoscopy attempts to achieve successful tracheal intubation
Time frame: during procedure
Lowest Systolic Blood Pressure
Lowest systolic blood pressure between induction and 2 min after intubation
Time frame: between induction and 2 minutes following procedure
| Milestone | Fluid Loading | Usual Care |
|---|---|---|
| Started | 168 | 169 |
| Completed | 168 | 169 |
| Not completed | 0 | 0 |
a composite endpoint defined as one or more of the following: * Death within 1 hour of intubation * Cardiac arrest within 1 hour of intubation * New systolic blood pressure \< 65 mmHg between induction and 2 minutes after completion of intubation * New or increased vasopressor receipt between induction and 2 minutes after completion of intubation
| Participants | Fluid Loading | Usual Care |
|---|---|---|
| Number of Participants With Cardiovascular Collapse | 33 | 31 |
What was the patient's vital status at the time of hospital discharge
| Participants | Fluid Loading | Usual Care |
|---|---|---|
| In-hospital Mortality | 48 | 59 |
Number of days alive and free of invasive ventilation in a 28-day period
| days | Fluid Loading | Usual Care |
|---|---|---|
| Ventilator-free Days | 20 (0 to 25) | 19 (0 to 25) |
Number of days alive and outside of an ICU in a 28 day period
| days | Fluid Loading | Usual Care |
|---|---|---|
| ICU-free Days | 16 (0 to 24) | 14 (0 to 23) |
Lowest arterial oxygen saturation between induction and 2 min after intubation
| percentage of hemoglobin | Fluid Loading | Usual Care |
|---|---|---|
| Lowest Arterial Oxygen Saturation | 94 (84 to 99) | 95 (82 to 99) |
Number of laryngoscopy attempts to achieve successful tracheal intubation
| attempts | Fluid Loading | Usual Care |
|---|---|---|
| Number of Laryngoscopy Attempts | 1 (1 to 1) | 1 (1 to 1) |
Lowest systolic blood pressure between induction and 2 min after intubation
| mmHg | Fluid Loading | Usual Care |
|---|---|---|
| Lowest Systolic Blood Pressure | 119 (95 to 140) | 119 (94 to 141) |
Collected over 28 days after enrollment and randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluid Loading | 48/168 (28.6%) | 0/168 (0%) | 0/168 (0%) |
| Usual Care | 59/169 (34.9%) | 0/169 (0%) | 0/169 (0%) |
All patients randomized were included in the baseline analysis
| Age, Continuous(years) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| Median | 61 (47 to 70) | 58 (46 to 68) | 60 (49 to 69) |
| Sex: Female, Male(Participants) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| Female | 81 | 73 | 154 |
| Male | 87 | 96 | 183 |
| Race/Ethnicity, Customized(Participants) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| White Race | 115 | 121 | 236 |
| Other | 53 | 48 | 101 |
| Region of Enrollment(participants) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| United States | 168 | 169 | 337 |
| Body-mass index(kg/m^2) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| Median | 27 (14 to 27) | 26 (22 to 32) | 26 (22 to 30) |
| Acute physiology and chronic health evaluation score(units on a scale, range 0 to 71) | Fluid Loading | Usual Care | Total |
|---|---|---|---|
| Median | 21 (14 to 27) | 20 (16 to 27) | 20 (16 to 27) |
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Louisiana State University Health Sciences Center in New Orleans