Trial Outcomes & Findings for Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial (NCT NCT02643381)

Results Overview

Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

801 participants

Primary outcome timeframe

Day 7

Results posted on

2021-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	Etomidate Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Overall Study STARTED	400	401
Overall Study COMPLETED	396	395
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Total n=791 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 15.2 • n=5 Participants	55.4 years STANDARD_DEVIATION 16.0 • n=7 Participants	55.6 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	150 Participants n=7 Participants	303 Participants n=5 Participants
Sex: Female, Male Male	243 Participants n=5 Participants	245 Participants n=7 Participants	488 Participants n=5 Participants
Race/Ethnicity, Customized White	250 Participants n=5 Participants	246 Participants n=7 Participants	496 Participants n=5 Participants
Race/Ethnicity, Customized Black	133 Participants n=5 Participants	122 Participants n=7 Participants	255 Participants n=5 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	27 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	141 Participants n=5 Participants	139 Participants n=7 Participants	280 Participants n=5 Participants
Region of Enrollment United States	396 participants n=5 Participants	395 participants n=7 Participants	791 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7

Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Survival at Day 7	306 Participants	336 Participants

SECONDARY outcome

Timeframe: Day 28

Survival is defined as the number of participants survived at day 28 following emergency endotracheal intubation

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Survival at Day 28	254 Participants	264 Participants

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 3, Day 4

Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems. Possible scores range from 0 to 24. Higher score indicates higher degree of organ dysfunction

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Sequential Organ Failure Assessment (SOFA) Scores Day 1	10.7 score on a scale Standard Deviation 4.6	10.9 score on a scale Standard Deviation 4.5
Sequential Organ Failure Assessment (SOFA) Scores Day 2	9.8 score on a scale Standard Deviation 5.1	9.5 score on a scale Standard Deviation 4.9
Sequential Organ Failure Assessment (SOFA) Scores Day 3	8.4 score on a scale Standard Deviation 5.3	8.4 score on a scale Standard Deviation 5.1
Sequential Organ Failure Assessment (SOFA) Scores Day 4	7.4 score on a scale Standard Deviation 5.2	7.4 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: From time of documented insertion until the time of documented removal, assessed up to 28 days

Duration (in days) from insertion to removal of mechanical ventilation

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Duration of Mechanical Ventilation	5 Days Interval 3.0 to 9.0	5 Days Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days

Time (in days) from start to end of catecholamine therapy

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Duration of Catecholamine Therapy	1 Days Interval 0.0 to 3.0	1 Days Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Assessed up to 28 days

Length (in days) of ICU stay

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Length of Stay in ICU	8 Days Interval 4.0 to 16.0	9 Days Interval 5.0 to 14.0

SECONDARY outcome

Timeframe: Day 28

New diagnosis of adrenal insufficiency will be assessed by the the primary treating medical or surgical team via chart review

Outcome measures

Outcome measures
Measure	Etomidate n=396 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Number of Participants With New Diagnosis of Adrenal Insufficiency	11 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediate (Day 1)

Population: Clinical information incomplete or missing from 5 patients randomized to Etomidate and 6 patients randomized to Ketamine.

This referrers to the number of documented intubation attempts necessary to intubate the patient.

Outcome measures

Outcome measures
Measure	Etomidate n=391 Participants Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=389 Participants Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Number of Attempts Necessary to Intubate 1 Attempt (successfully intubated)	357 Participants	355 Participants
Number of Attempts Necessary to Intubate 2 Attempts (successfully intubated)	29 Participants	26 Participants
Number of Attempts Necessary to Intubate 3 or More Attempts (successfully intubated)	4 Participants	5 Participants
Number of Attempts Necessary to Intubate Surgical Airway	1 Participants	3 Participants

Adverse Events

Etomidate

Serious events: 10 serious events

Other events: 0 other events

Deaths: 142 deaths

Ketamine

Serious events: 9 serious events

Other events: 0 other events

Deaths: 131 deaths

Serious adverse events

Serious adverse events
Measure	Etomidate n=396 participants at risk Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.	Ketamine n=395 participants at risk Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Injury, poisoning and procedural complications Oral/ dental trauma	0.51% 2/396 • Number of events 2 • Day 1-28 Adverse study-related events	1.0% 4/395 • Number of events 4 • Day 1-28 Adverse study-related events
Injury, poisoning and procedural complications Bleeding	0.00% 0/396 • Day 1-28 Adverse study-related events	0.76% 3/395 • Number of events 3 • Day 1-28 Adverse study-related events
Injury, poisoning and procedural complications Aspiration	2.0% 8/396 • Number of events 8 • Day 1-28 Adverse study-related events	0.51% 2/395 • Number of events 2 • Day 1-28 Adverse study-related events

Other adverse events

Adverse event data not reported

Additional Information

Gerald Matchett

UT-Southwestern Medical Center

Phone: 214-648-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place