Trial Outcomes & Findings for Randomized Trial of Sedative Choice for Intubation (NCT NCT05277896)
NCT ID: NCT05277896
Last Updated: 2026-03-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2367 participants
Primary outcome timeframe
28 days
Results posted on
2026-03-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1177
|
1190
|
|
Overall Study
COMPLETED
|
1173
|
1186
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data on body-mass index were missing for 19 patients (0.8%): 8 in the ketamine group and 11 in the etomidate group.
Baseline characteristics by cohort
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
Total
n=2365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 In years
n=1176 Participants
|
60 In years
n=1189 Participants
|
60 In years
n=2365 Participants
|
|
Sex: Female, Male
Female
|
498 Participants
n=1176 Participants
|
492 Participants
n=1189 Participants
|
990 Participants
n=2365 Participants
|
|
Sex: Female, Male
Male
|
678 Participants
n=1176 Participants
|
697 Participants
n=1189 Participants
|
1375 Participants
n=2365 Participants
|
|
Race/Ethnicity, Customized
Race or ethnic group · Non-Hispanic White
|
686 Participants
n=1176 Participants
|
706 Participants
n=1189 Participants
|
1392 Participants
n=2365 Participants
|
|
Race/Ethnicity, Customized
Race or ethnic group · Non-Hispanic Black
|
300 Participants
n=1176 Participants
|
287 Participants
n=1189 Participants
|
587 Participants
n=2365 Participants
|
|
Race/Ethnicity, Customized
Race or ethnic group · Hispanic
|
130 Participants
n=1176 Participants
|
132 Participants
n=1189 Participants
|
262 Participants
n=2365 Participants
|
|
Race/Ethnicity, Customized
Race or ethnic group · Other
|
60 Participants
n=1176 Participants
|
64 Participants
n=1189 Participants
|
124 Participants
n=2365 Participants
|
|
Weight
|
78.9 In kilograms
n=1176 Participants
|
78.5 In kilograms
n=1189 Participants
|
78.6 In kilograms
n=2365 Participants
|
|
Body-Mass Index
|
26.9 kg/m²
n=1168 Participants • Data on body-mass index were missing for 19 patients (0.8%): 8 in the ketamine group and 11 in the etomidate group.
|
26.7 kg/m²
n=1178 Participants • Data on body-mass index were missing for 19 patients (0.8%): 8 in the ketamine group and 11 in the etomidate group.
|
26.8 kg/m²
n=2346 Participants • Data on body-mass index were missing for 19 patients (0.8%): 8 in the ketamine group and 11 in the etomidate group.
|
|
Location of intubation
Emergency Department
|
663 Participants
n=1176 Participants
|
655 Participants
n=1189 Participants
|
1318 Participants
n=2365 Participants
|
|
Location of intubation
Intensive Care Unit
|
513 Participants
n=1176 Participants
|
534 Participants
n=1189 Participants
|
1047 Participants
n=2365 Participants
|
|
Median Glasgow Coma Scale Score
|
11 Numeric score
n=1170 Participants • Glasgow Coma Scale scores were missing for 10 patients (0.4%): 6 in the ketamine group and 4 in the etomidate group.
|
11 Numeric score
n=1185 Participants • Glasgow Coma Scale scores were missing for 10 patients (0.4%): 6 in the ketamine group and 4 in the etomidate group.
|
11 Numeric score
n=2355 Participants • Glasgow Coma Scale scores were missing for 10 patients (0.4%): 6 in the ketamine group and 4 in the etomidate group.
|
|
Median APACHE II Score
|
18 Numeric score
n=1176 Participants
|
18 Numeric score
n=1189 Participants
|
18 Numeric score
n=2365 Participants
|
|
Median highest heart rate within 1 hr before enrollment
|
107 Beats per minute
n=1176 Participants
|
108 Beats per minute
n=1189 Participants
|
108 Beats per minute
n=2365 Participants
|
|
Median lowest systolic blood pressure within 1 hr before enrollment
|
115 mm Hg
n=1165 Participants • 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.
|
114 mm Hg
n=1178 Participants • 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.
|
115 mm Hg
n=2343 Participants • 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.
|
|
Receipt of vasopressors within 1 hr before enrollment
|
246 Participants
n=1176 Participants
|
274 Participants
n=1189 Participants
|
520 Participants
n=2365 Participants
|
|
Chronic conditions
Adrenal insufficiency or glucocorticoids
|
136 Participants
n=1176 Participants
|
129 Participants
n=1189 Participants
|
265 Participants
n=2365 Participants
|
|
Chronic conditions
Cirrhosis
|
165 Participants
n=1176 Participants
|
166 Participants
n=1189 Participants
|
331 Participants
n=2365 Participants
|
|
Chronic conditions
Congestive heart failure
|
175 Participants
n=1176 Participants
|
158 Participants
n=1189 Participants
|
333 Participants
n=2365 Participants
|
|
Chronic conditions
Coronary artery disease
|
141 Participants
n=1176 Participants
|
153 Participants
n=1189 Participants
|
294 Participants
n=2365 Participants
|
|
Chronic conditions
Hypertension
|
536 Participants
n=1176 Participants
|
533 Participants
n=1189 Participants
|
1069 Participants
n=2365 Participants
|
|
Chronic conditions
Cancer
|
227 Participants
n=1176 Participants
|
215 Participants
n=1189 Participants
|
442 Participants
n=2365 Participants
|
|
Acute conditions
Acute cardiac condition
|
216 Participants
n=1176 Participants
|
223 Participants
n=1189 Participants
|
439 Participants
n=2365 Participants
|
|
Acute conditions
Acute respiratory condition
|
678 Participants
n=1176 Participants
|
683 Participants
n=1189 Participants
|
1361 Participants
n=2365 Participants
|
|
Acute conditions
Acute neurologic condition
|
125 Participants
n=1176 Participants
|
121 Participants
n=1189 Participants
|
246 Participants
n=2365 Participants
|
|
Acute conditions
Sepsis or septic shock
|
539 Participants
n=1176 Participants
|
565 Participants
n=1189 Participants
|
1104 Participants
n=2365 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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.
Outcome measures
| Measure |
Ketamine Group
n=1173 Participants
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
n=1186 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.
|
|---|---|---|
|
All-cause, 28-day, In-hospital Mortality
|
330 Participants
|
345 Participants
|
SECONDARY outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
A composite of any of the following between induction and 2 minutes after intubation: * Systolic blood pressure \< 65 mmHg * New or increased vasopressors * Cardiac arrest not resulting in death within 1 hour of induction * Cardiac arrest resulting in death within 1 hour of induction
Outcome measures
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
|---|---|---|
|
Cardiovascular Collapse
Cardiovascular collapse between induction of anesthesia and 2 minutes after intubation
|
260 Participants
|
202 Participants
|
|
Cardiovascular Collapse
Systolic blood pressure <65 mm Hg
|
73 Participants
|
64 Participants
|
|
Cardiovascular Collapse
Receipt of a new or increased dose of vasopressors
|
251 Participants
|
189 Participants
|
|
Cardiovascular Collapse
Cardiac arrest
|
12 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Population: 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.
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
Outcome measures
| Measure |
Ketamine Group
n=1172 Participants
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
n=1184 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.
|
|---|---|---|
|
Cormack-Lehane Grade of Glottic View
Grade 4
|
15 Participants
|
14 Participants
|
|
Cormack-Lehane Grade of Glottic View
Grade 1
|
822 Participants
|
831 Participants
|
|
Cormack-Lehane Grade of Glottic View
Grade 2
|
295 Participants
|
290 Participants
|
|
Cormack-Lehane Grade of Glottic View
Grade 3
|
40 Participants
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Population: 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.
Median time from induction of anesthesia to intubation
Outcome measures
| Measure |
Ketamine Group
n=1162 Participants
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
n=1177 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.
|
|---|---|---|
|
Time From Induction to Successful Tracheal Intubation
|
112 Time in seconds
Interval 86.0 to 155.0
|
103 Time in seconds
Interval 80.0 to 134.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
Percentage of oxygenated hemoglobin
Outcome measures
| Measure |
Ketamine Group
n=1127 Participants
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
n=1132 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.
|
|---|---|---|
|
Lowest Oxygen Saturation Between Induction and Two Minutes After Intubation
|
97 Percentage of oxygenated hemoglobin
Interval 90.0 to 100.0
|
97 Percentage of oxygenated hemoglobin
Interval 89.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
Outcome measures
| Measure |
Ketamine Group
n=1127 Participants
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
n=1132 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.
|
|---|---|---|
|
Lowest Oxygen Saturation < 80% Between Induction to Two Minutes After Intubation
|
125 Participants
|
126 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
Median highest and lowest systolic blood pressure from induction to two minutes after intubation
Outcome measures
| Measure |
Ketamine Group
n=1138 Participants
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
n=1159 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.
|
|---|---|---|
|
Highest and Lowest Systolic Blood Pressure From Induction to Two Minutes After Intubation
Highest systolic blood pressure
|
140 mm Hg
Interval 115.0 to 164.0
|
141 mm Hg
Interval 118.0 to 168.0
|
|
Highest and Lowest Systolic Blood Pressure From Induction to Two Minutes After Intubation
Lowest systolic blood pressure
|
112 mm Hg
Interval 92.0 to 138.0
|
118 mm Hg
Interval 98.0 to 141.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
Outcome measures
| Measure |
Ketamine Group
n=1138 Participants
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
n=1159 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.
|
|---|---|---|
|
Systolic Blood Pressure > 180 Between Induction and Two Minutes After Intubation
|
154 Participants
|
191 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationPopulation: 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.
Outcome measures
| Measure |
Ketamine Group
n=1138 Participants
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
n=1159 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.
|
|---|---|---|
|
Systolic Blood Pressure < 65 mmHg Between Induction and 2 Minutes After Intubation
|
73 Participants
|
64 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationReceipt of new or increased vasopressor between induction and 2 minutes after intubation
Outcome measures
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
|---|---|---|
|
New or Increased Vasopressor Between Induction and 2 Minutes After Intubation
|
251 Participants
|
189 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationOutcome measures
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
|---|---|---|
|
Cardiac Arrest Within 2 Minutes of Intubation Not Resulting in Death Within 1 Hour of Induction
|
9 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationOutcome measures
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
|---|---|---|
|
Cardiac Arrest Within 2 Minutes of Intubation Resulting in Death Within 1 Hour of Induction
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Median ventilator-free days to study day 28, with follow-up data censored at the time of hospital discharge
Outcome measures
| Measure |
Ketamine Group
n=1173 Participants
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
n=1186 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.
|
|---|---|---|
|
Ventilator-free Days to Study Day 28
|
23 time in days
Interval 0.0 to 26.0
|
23 time in days
Interval 0.0 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Median vasopressor-free days to study day 28, with follow-up data censored at the time of hospital discharge
Outcome measures
| Measure |
Ketamine Group
n=1173 Participants
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
n=1186 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.
|
|---|---|---|
|
Vasopressor-free Days to Study Day 28
|
25 time in days
Interval 0.0 to 28.0
|
25 time in days
Interval 0.0 to 28.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Median ICU-free days to study day 28, with follow-up data censored at the time of hospital discharge
Outcome measures
| Measure |
Ketamine Group
n=1173 Participants
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
n=1186 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.
|
|---|---|---|
|
ICU-free Days to Study Day 28
|
20 time in days
Interval 0.0 to 24.0
|
19 time in days
Interval 0.0 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPopulation: 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.
Median systolic blood pressure at 24 hours after enrollment.
Outcome measures
| Measure |
Ketamine Group
n=1075 Participants
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
n=1077 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.
|
|---|---|---|
|
Systolic Blood Pressure at 24 Hours After Induction
|
114 mm Hg
Interval 102.0 to 130.0
|
114 mm Hg
Interval 103.0 to 129.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPopulation: 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.
Outcome measures
| Measure |
Ketamine Group
n=1079 Participants
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
n=1082 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.
|
|---|---|---|
|
Receipt of Vasopressors at 24 Hours After Induction
|
420 Participants
|
458 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 hourOutcome measures
| Measure |
Ketamine Group
n=1176 Participants
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
n=1189 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.
|
|---|---|---|
|
Cardiac Arrest Between Induction and 1 Hour After Induction
|
26 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Population: This analysis includes the 2360 patients who underwent intubation with a laryngoscope.
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.
Outcome measures
| Measure |
Ketamine Group
n=1173 Participants
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
n=1187 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.
|
|---|---|---|
|
Successful Intubation on the First Attempt
|
1005 Participants
|
1029 Participants
|
Adverse Events
Ketamine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 330 deaths
Etomidate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 345 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew W. Semler
Vanderbilt University Medical Center
Phone: 615-875-4681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place