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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL153584 | U.S. NIH Grant/Contract | View source | |
| BPS-2022C3-30021 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Patient-Centered Outcomes Research Institute | OTHER |
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Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation.
Each year more than 1.5 million critically ill adults receive invasive mechanical ventilation in the United States, at a cost of nearly $30 billion dollars annually. Recent research has dramatically improved patient safety during the maintenance, weaning, and liberation stages of invasive mechanical ventilation. In contrast, the optimal approach to the initiation of mechanical ventilation remains an important knowledge gap in the care of adults with respiratory failure. Among critically ill adults, life-threatening complications during tracheal intubation and initiation of invasive mechanical ventilation remain common. One in five patients experiences hypotension and one-in-forty experiences cardiac arrest during the two-minute tracheal intubation procedure
Cardiovascular collapse is a peri-procedural outcome defined as severe hypotension, new or increased vasopressors, cardiac arrest or death. The occurrence of cardiovascular collapse during tracheal intubation of critically ill adults increases patients' risk of in-hospital mortality. Randomized trials examining intubation technique commonly target cardiovascular collapse as an outcome. Adherence to recommended best-practices for tracheal intubation (e.g., preoxygenation, optimization of patient positioning, and procedural checklists) are insufficient to prevent 20-40% of critically ill adults from experiencing cardiovascular collapse during tracheal intubation.
Rapid sequence induction and tracheal intubation, the most common method of intubation for critically ill patients, is the nearly simultaneous administration of a sedative medication and neuromuscular blocking medication. The ideal sedative agent for rapid sequence intubation would rapidly provide a deep state of unconsciousness and analgesia without causing hemodynamic side effects. No available agent meets all of these criteria. The administration of any of the available sedative agents at a dose large enough to rapidly induce unconsciousness contributes to cardiovascular collapse through vasodilation, decreased cardiac filling pressures from sedation-induced venodilation, and decreased endogenous catecholamines. While all sedatives commonly used during emergency tracheal intubation of critically ill patients have been associated with unsatisfactory hypotension (21 CFR 50.24(a)(1)), ketamine and etomidate are the medications used most commonly in clinical practice due to their rapid onset and favorable hemodynamic profiles relative to the other available sedatives. Other sedatives that have been used in some settings during rapid sequence intubation include benzodiazepines, propofol, and barbiturates. Benzodiazepines do not provide any analgesia and are associated with an unsatisfactory degree of hypotension, with a drop in mean arterial blood pressure of 10 to 25 percent, even among healthy patients. At present, barbiturates are rarely used for tracheal intubation in the US because of unsatisfactorily high rates of post-intubation hypotension and evidence of negative cardiac ionotropy. While propofol is commonly used to induce anesthesia among healthy patients, and is commonly administered as a continuous infusion to maintain sedation for critically ill patients, it is used less commonly as a bolus during tracheal intubation of critically ill patients because it has been suggested to cause unsatisfactorily high rates of hypotension and cardiac depression, compared to ketamine or etomidate.
Ketamine is a phencyclidine derivative that provides anesthesia via its effect at the NMDA receptors. Ketamine has been approved by the United States Food and Drug Administration (FDA) with approved indications including "use as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation" and "induction of anesthesia prior to the administration of other general anesthetic agents." In addition to sedation, ketamine provides significant amnesia and analgesia via action at the opioid receptors, and is commonly used for procedural sedation and as a continuous infusion to control pain.
Ketamine activates the sympathetic nervous system, stimulating the release of catecholamines, which may increase heart rate and blood pressure during intubation and prevent peri-procedural cardiovascular collapse. Conversely ketamine has direct negative ionotropic effects, leading to myocardial depression. While the myocardial depression may be counteracted by increased catecholamine release, ketamine could cause cardiovascular collapse among patients with depleted catecholamine stores, and case reports of unexpected cardiac arrest during intubations with ketamine have been published. Despite stimulating the release of catecholamines, using ketamine as the induction agent during emergency tracheal intubation does not appear to frequently cause or worsen hypertensive urgency or emergency; however, the literature on this topic is limited to case reports.
Historically, concerns have been raised that ketamine might increase intracranial pressure and cause deleterious decreases in cranial perfusion pressure. Recent studies have suggested, however, that ketamine may be associated with a beneficial increase in cranial perfusion pressure as a result of increased mean arterial pressure, and a recent, large before-after study showed no significant differences in clinical outcomes for trauma patients intubated with ketamine versus etomidate.
Etomidate is an imidazole derivative that acts at gamma-aminobutyric acid "A" (GABA) receptors. Etomidate has been approved by the FDA with an indication for "induction of general anesthesia." In a recent review of more than 19,000 intubations by a large, multicenter emergency medicine registry, etomidate was the most commonly used sedative during emergency tracheal intubation.
Etomidate causes less hemodynamic instability than propofol or midazolam, but the data regarding the relative risk of hemodynamical instability with etomidate, compared to ketamine, is unclear. It was initially suggested that ketamine might cause less hypotension than etomidate, given ketamine's ability to stimulate the release of catecholamines, but a recent observational study comparing ketamine and etomidate among nearly 7,000 critically ill adults undergoing tracheal intubation in emergency departments suggested that ketamine was independently associated with an increased risk of peri-intubation hypotension.
Etomidate was initially used both for induction of anesthesia and as a continuous drip for maintenance of anesthesia. Its use as a continuous drip for maintenance of anesthesia was halted after it was discovered that prolonged use of etomidate causes inhibition of adrenal cortisol production by blockade of 11-β-hydroxylase, leading to adrenal insufficiency, and increased mortality. Etomidate use as a single bolus for induction of anesthesia has continued, but numerous studies have demonstrated that even a single dose of etomidate can cause transient adrenal insufficiency. The clinical significance of this relative adrenal insufficiency, however, remains unclear. Contrasting observational studies have suggested that etomidate may have positive, negative or neutral impacts on mortality.
Two randomized trials have directly compared ketamine to etomidate for RSI among critically ill adults. The Ketased trial, published in 2009, was a 469-patient trial conducted across 12 emergency medical services and emergency departments in France. Because many patients were enrolled in the pre-hospital setting without continuous blood pressure monitoring, peri-procedural outcomes such as cardiovascular collapse were not collected, and the results were indeterminate, in regards to the primary outcome, average Sequential Organ Failure Assessment (SOFA) scores in the 72 hours after intubation. The results, however, demonstrated significant heterogeneity. Patients with trauma (for whom increased intracranial pressure from ketamine may be important) experienced a non-significant 4% absolute increase in mortality when intubated with ketamine compared to etomidate. All other patients experienced a non-significantly lower mortality when intubated with ketamine, particularly patients with sepsis who experienced a non-significant 7% absolute mortality benefit (and in whom adrenal insufficiency from etomidate may be particularly important).
The EvK trial, published in January 2022, was a single-center, 801-patient trial conducted among hospitalized patients at a single hospital in Texas.61 Survival at 7 days, the primary outcome of the EvK trial, was higher in the ketamine group, compared to the etomidate group (85.1% vs 77.3%; p=0.005), but this difference was attenuated by day 28, at which point it was no longer significant (66.8% vs 64.1%, p=0.294). The conclusion of this single-center trial was that "there was no significant difference in survival by Day 28", however it was noted that this "could represent a small but durable long-term survival effect, one which our trial was under-powered to detect."
Experts have pointed out that the currently available data on sedative choice during tracheal intubation of critically ill patients are inadequate and have called for additional randomized clinical trials. Because (1) cardiovascular collapse is common during tracheal intubation of critically ill adults (2) sedatives are a driver of cardiovascular collapse, (3) use of ketamine or etomidate varies between centers, specialties, and operators, and (4) prior data suggests the potential for ketamine to significantly decrease mortality for patients without trauma, a large, multicenter trial is needed to determine the effects of ketamine and etomidate on mortality in non-traumatic critical illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Group | Active Comparator | Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care. |
|
| Etomidate Group | Active Comparator | Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause, 28-day, In-hospital Mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Collapse | A composite of any of the following between induction and 2 minutes after intubation:
| from induction to 2 minutes following tracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Cormack-Lehane Grade of Glottic View | Grade of glottic view on first attempt at intubation: Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen | Duration of procedure (minutes) |
| Time From Induction to Successful Tracheal Intubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Casey, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Matthew W Semler, MD, MSc | Vanderbilt University Medical Center | Study Chair |
| Todd W Rice, MD, MSc | Vanderbilt University Medical Center | Study Director |
| Wesley H Self, MD, MPH | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35233 | United States | ||
| University of Colorado Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41957629 | Derived | Lewis AA, Israel TL, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Prekker ME, Robinson AE, Palakshappa JA, Gaillard JP, Stewart LJ, Beach LL, Lloyd BD, DeMasi SC, Hays MA, Withers C, Sullivan AE, Lyle C, Whitson MR, Gould B, Rice TW, Self WH, Han JH, Semler MW, Casey JD; RSI investigators and the Pragmatic Critical Care Research Group. Community consultation and public disclosure for the Randomized Trial of Sedative Choice for Intubation. Trials. 2026 Apr 10;27(1):368. doi: 10.1186/s13063-026-09665-9. | |
| 41472917 |
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Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator
Following publication. No end date
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Group | Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care. |
| FG001 | Etomidate Group | Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Group | Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | All-cause, 28-day, In-hospital Mortality | A total of 6 patients (0.3%) withdrew from follow-up before day 28 and were missing data for 28-day outcomes: 3 in the ketamine group and 3 in the etomidate group. | Posted | Count of Participants | Participants | 28 days |
|
The time interval during which patients will be monitored for the occurrence of adverse events begins at randomization and ends at the first of hospital discharge or 28 days.
Adverse events considered reportable and collected in the RSI trial include:
Study-specific clinical outcomes, including serious outcomes such as organ failures and death, are systematically recorded and are exempt from AE reporting unless related to study procedures.
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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 | Ketamine Group | Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care. Ketamine: Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew W. Semler | Vanderbilt University Medical Center | 615-875-4681 | matthew.w.semler@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2025 | Feb 13, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2024 | Aug 21, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005045 | Etomidate |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Etomidate | Drug | Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation |
|
Median time from induction of anesthesia to intubation |
| Duration of procedure (minutes) |
| Lowest Oxygen Saturation Between Induction and Two Minutes After Intubation | Percentage of oxygenated hemoglobin | from induction to 2 minutes following tracheal intubation |
| Lowest Oxygen Saturation < 80% Between Induction to Two Minutes After Intubation | from induction to 2 minutes following tracheal intubation |
| Highest and Lowest Systolic Blood Pressure From Induction to Two Minutes After Intubation | Median highest and lowest systolic blood pressure from induction to two minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Systolic Blood Pressure > 180 Between Induction and Two Minutes After Intubation | from induction to 2 minutes following tracheal intubation |
| 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 | Receipt of new or increased vasopressor between induction and 2 minutes after intubation | from induction to 2 minutes following tracheal intubation |
| Cardiac Arrest Within 2 Minutes of Intubation Not Resulting in Death Within 1 Hour of Induction | from induction to 2 minutes following tracheal intubation |
| Cardiac Arrest Within 2 Minutes of Intubation Resulting in Death Within 1 Hour of Induction | from induction to 2 minutes following tracheal intubation |
| Ventilator-free Days to Study Day 28 | Median ventilator-free days to study day 28, with follow-up data censored at the time of hospital discharge | 28 days |
| Vasopressor-free Days to Study Day 28 | Median vasopressor-free days to study day 28, with follow-up data censored at the time of hospital discharge | 28 days |
| ICU-free Days to Study Day 28 | Median ICU-free days to study day 28, with follow-up data censored at the time of hospital discharge | 28 days |
| Systolic Blood Pressure at 24 Hours After Induction | Median systolic blood pressure at 24 hours after enrollment. | 24 hours |
| Receipt of Vasopressors at 24 Hours After Induction | 24 hours |
| Cardiac Arrest Between Induction and 1 Hour After Induction | 1 hour |
| Successful Intubation on the First Attempt | Placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth. | Duration of procedure (minutes) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Derived |
| DeMasi SC, Imhoff B, Lewis AA, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, Van Schaik GWW, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Lyle C, Gandotra S, Lacy AJ, Sherlin KC, Carlson GK, Maycee Cain J, Redman B, Higgins C, Withers C, Beach LL, Gould B, McIntosh J, Lloyd BD, Israel TL, Wang L, Rice TW, Self WH, Han JH, Casey JD, Semler MW. Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation. CHEST Crit Care. 2025 Sep;3(3):100177. doi: 10.1016/j.chstcc.2025.100177. Epub 2025 Aug 13. |
| 41369227 | Derived | Casey JD, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, DeMasi SC, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Marvi TK, Scott BK, Alber SM, Lyle C, Gandotra S, Van Schaik GW, Lacy AJ, Sherlin KC, Erickson HL, Cain JM, Redman B, Beach LL, Gould B, McIntosh J, Lewis AA, Lloyd BD, Israel TL, Imhoff B, Wang L, Spicer AB, Churpek MM, Rice TW, Self WH, Han JH, Semler MW; RSI Investigators and the Pragmatic Critical Care Research Group. Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2026 Apr 23;394(16):1608-1620. doi: 10.1056/NEJMoa2511420. Epub 2025 Dec 9. |
| 39867415 | Derived | DeMasi SC, Imhoff B, Lewis AA, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, Van Schaik GWW, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Lyle C, Gandotra S, Lacy AJ, Sherlin KC, Carlson GK, Cain JM, Redman B, Higgins C, Withers C, Beach LL, Gould B, McIntosh J, Lloyd BD, Israel TL, Wang L, Rice TW, Self WH, Han JH, Casey JD, Semler MW; RSI investigators and the Pragmatic Critical Care Research Group. Protocol and Statistical Analysis Plan for the Randomized Trial of Sedative Choice for Intubation (RSI). medRxiv [Preprint]. 2025 Jan 18:2025.01.18.25320768. doi: 10.1101/2025.01.18.25320768. |
| BG001 | Etomidate Group | Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care. |
| BG002 | Total | Total of all reporting groups |
| In years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | In kilograms |
|
| Body-Mass Index | Weight in kilograms divided by the square of the height in meters | Data on body-mass index were missing for 19 patients (0.8%): 8 in the ketamine group and 11 in the etomidate group. | Median | Inter-Quartile Range | kg/m² |
|
| Location of intubation | Count of Participants | Participants |
|
| Median Glasgow Coma Scale Score | Glasgow Coma Scale scores range from 3 to 15, with lower scores indicating a lower level of consciousness. | Glasgow Coma Scale scores were missing for 10 patients (0.4%): 6 in the ketamine group and 4 in the etomidate group. | Median | Inter-Quartile Range | Numeric score |
|
| Median APACHE II Score | Scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II range from 0 to 71, with higher scores indicating a greater severity of illness. | Median | Inter-Quartile Range | Numeric score |
|
| Median highest heart rate within 1 hr before enrollment | Median | Inter-Quartile Range | Beats per minute |
|
| Median lowest systolic blood pressure within 1 hr before enrollment | Data on the lowest systolic blood pressure within 1 hour before enrollment were missing for 22 patients (0.9%): 11 in the ketamine group and 11 in the etomidate group. | Median | Inter-Quartile Range | mm Hg |
|
| Receipt of vasopressors within 1 hr before enrollment | Count of Participants | Participants |
|
| Chronic conditions | Count of Participants | Participants |
|
| Acute conditions | Count of Participants | Participants |
|
Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care. |
|
|
| Secondary | Cardiovascular Collapse | A composite of any of the following between induction and 2 minutes after intubation:
| Data on systolic blood pressure during the interval between induction of anesthesia and 2 minutes after intubation were missing for 68 patients (2.9%): 38 in the ketamine group and 30 in the etomidate group. | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Cormack-Lehane Grade of Glottic View | Grade of glottic view on first attempt at intubation: Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen | Data on grade of view were missing in 4 patients (0.2%) - 1 patient in the ketamine group and 3 patients in the etomidate group. | Posted | Count of Participants | Participants | Duration of procedure (minutes) |
|
|
|
| Other Pre-specified | Time From Induction to Successful Tracheal Intubation | Median time from induction of anesthesia to intubation | Data on the time from induction of anesthesia to intubation were missing for 26 patients (1.1%): 14 in the ketamine group and 12 in the etomidate group. | Posted | Median | Inter-Quartile Range | Time in seconds | Duration of procedure (minutes) |
|
|
|
| Other Pre-specified | Lowest Oxygen Saturation Between Induction and Two Minutes After Intubation | Percentage of oxygenated hemoglobin | Data on the oxygen saturation during the interval between induction of anesthesia and 2 minutes after intubation were missing for 106 patients (4.5%): 49 in the ketamine group and 57 in the etomidate group. | Posted | Median | Inter-Quartile Range | Percentage of oxygenated hemoglobin | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Lowest Oxygen Saturation < 80% Between Induction to Two Minutes After Intubation | Data on the oxygen saturation during the interval between induction of anesthesia and 2 minutes after intubation were missing for 106 patients (4.5%): 49 in the ketamine group and 57 in the etomidate group. | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Highest and Lowest Systolic Blood Pressure From Induction to Two Minutes After Intubation | Median highest and lowest systolic blood pressure from induction to two minutes after intubation | Data on systolic blood pressure during the interval between induction of anesthesia and 2 minutes after intubation were missing for 68 patients (2.9%): 38 in the ketamine group and 30 in the etomidate group. | Posted | Median | Inter-Quartile Range | mm Hg | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Systolic Blood Pressure > 180 Between Induction and Two Minutes After Intubation | Data on systolic blood pressure during the interval between induction of anesthesia and 2 minutes after intubation were missing for 68 patients (2.9%): 38 in the ketamine group and 30 in the etomidate group. | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Systolic Blood Pressure < 65 mmHg Between Induction and 2 Minutes After Intubation | Data on systolic blood pressure during the interval between induction of anesthesia and 2 minutes after intubation were missing for 68 patients (2.9%): 38 in the ketamine group and 30 in the etomidate group. | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | New or Increased Vasopressor Between Induction and 2 Minutes After Intubation | Receipt of new or increased vasopressor between induction and 2 minutes after intubation | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Cardiac Arrest Within 2 Minutes of Intubation Not Resulting in Death Within 1 Hour of Induction | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Cardiac Arrest Within 2 Minutes of Intubation Resulting in Death Within 1 Hour of Induction | Posted | Count of Participants | Participants | from induction to 2 minutes following tracheal intubation |
|
|
|
| Other Pre-specified | Ventilator-free Days to Study Day 28 | Median ventilator-free days to study day 28, with follow-up data censored at the time of hospital discharge | A total of 6 patients (0.3%) withdrew from follow-up before day 28 and were missing data for 28-day outcomes: 3 in the ketamine group and 3 in the etomidate group. | Posted | Median | Inter-Quartile Range | time in days | 28 days |
|
|
|
| Other Pre-specified | Vasopressor-free Days to Study Day 28 | Median vasopressor-free days to study day 28, with follow-up data censored at the time of hospital discharge | A total of 6 patients (0.3%) withdrew from follow-up before day 28 and were missing data for 28-day outcomes: 3 in the ketamine group and 3 in the etomidate group. | Posted | Median | Inter-Quartile Range | time in days | 28 days |
|
|
|
| Other Pre-specified | ICU-free Days to Study Day 28 | Median ICU-free days to study day 28, with follow-up data censored at the time of hospital discharge | A total of 6 patients (0.3%) withdrew from follow-up before day 28 and were missing data for 28-day outcomes: 3 in the ketamine group and 3 in the etomidate group. | Posted | Median | Inter-Quartile Range | time in days | 28 days |
|
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|
| Other Pre-specified | Systolic Blood Pressure at 24 Hours After Induction | Median systolic blood pressure at 24 hours after enrollment. | Data on systolic blood pressure at 24 hours after enrollment were unavailable for the 204 patients (8.6%) who died or were discharged before 24 hours. These data were missing for 9 patients (0.4%): 4 in the ketamine group and 5 in the etomidate group. | Posted | Median | Inter-Quartile Range | mm Hg | 24 hours |
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| Other Pre-specified | Receipt of Vasopressors at 24 Hours After Induction | Data on the ongoing receipt of vasopressors at 24 hours after enrollment were unavailable for the 204 patients (8.6%) who died or were discharged before 24 hours; 97 were in the ketamine group and 107 were in the etomidate group. | Posted | Count of Participants | Participants | 24 hours |
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|
|
| Other Pre-specified | Cardiac Arrest Between Induction and 1 Hour After Induction | Posted | Count of Participants | Participants | 1 hour |
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| Other Pre-specified | Successful Intubation on the First Attempt | Placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth. | This analysis includes the 2360 patients who underwent intubation with a laryngoscope. | Posted | Count of Participants | Participants | Duration of procedure (minutes) |
|
|
|
| 330 |
| 1,176 |
| 0 |
| 1,176 |
| 0 |
| 1,176 |
| EG001 | Etomidate Group | Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care. Etomidate: Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation | 345 | 1,189 | 0 | 1,189 | 0 | 1,189 |
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Hispanic |
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| Other |
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| Systolic blood pressure <65 mm Hg |
|
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| Receipt of a new or increased dose of vasopressors |
|
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| Cardiac arrest |
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|
| Grade 3 |
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| Grade 4 |
|