Cardiopulmonary ArrestPhase 4EvKNCT02643381
Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
A Phase 4 study testing Etomidate, Ketamine and Emergency Endotracheal Intubation in people with Cardiopulmonary Arrest and Respiratory Arrest, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest, Respiratory Arrest
- What is being tested?
- Etomidate, Ketamine and Emergency Endotracheal Intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2016to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (male or female) requiring emergency endotracheal intubation.
Who cannot join
- Children (<18 years old).
- Women who are known to be pregnant.
- Any patient who has been previously randomized in the EvK Trial.
- Patients who require endotracheal intubation without sedative medication. For example, patients in full cardiac arrest.
- Patients with a known allergy to ketamine or etomidate.
- Any individual wearing a MedAlert bracelet indicating that he/she has formally opted out of the EvK Trial.
Trial locations and contacts
1 site in 1 country.
About this study
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.
Read the detailed description
Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.
The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.
Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).
- Conditions
- Cardiopulmonary Arrest, Respiratory Arrest
- Being tested
- Etomidate, Ketamine, Emergency Endotracheal Intubation, Mechanical Ventilation
- Keywords
- etomidate, ketamine, endotracheal intubation, anesthesia induction medications
- Medical subject headings
- Heart Arrest, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
KetamineDrug
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
Emergency Endotracheal IntubationProcedure or surgery
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 VentilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Experimental | Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. Receives: Drug: Etomidate; Procedure: Emergency Endotracheal Intubation; Device: Mechanical Ventilation |
| Ketamine | Experimental | Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. Receives: Drug: Ketamine; Procedure: Emergency Endotracheal Intubation; Device: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at Day 7
Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation
Measured: Day 7
Secondary outcomes (7)
Survival at Day 28
Survival is defined as the number of participants survived at day 28 following emergency endotracheal intubation
Measured: Day 28
Sequential Organ Failure Assessment (SOFA) Scores
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
Measured: Day 1, Day 2, Day 3, Day 4
Duration of Mechanical Ventilation
Duration (in days) from insertion to removal of mechanical ventilation
Measured: From time of documented insertion until the time of documented removal, assessed up to 28 days
Duration of Catecholamine Therapy
Time (in days) from start to end of catecholamine therapy
Measured: From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
Length of Stay in ICU
Length (in days) of ICU stay
Measured: Assessed up to 28 days
Number of Participants With New Diagnosis of Adrenal Insufficiency
New diagnosis of adrenal insufficiency will be assessed by the the primary treating medical or surgical team via chart review
Measured: Day 28
Number of Attempts Necessary to Intubate
This referrers to the number of documented intubation attempts necessary to intubate the patient.
Measured: Immediate (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start6 Jun 2016
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Matchett, University of Texas Southwestern Medical Center
- Investigators
- Gerald Matchett, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643381
- Sponsor's protocol ID
- 022015-023
- Acronym
- EvK
- Status last verified
- Nov 2021
- First submitted
- 11 Dec 2015
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Aggregate anonymous data will be published in accord with our IRB approval.
Publications
Matchett G, Ryan TJ, Sunna MC, Lee SC, Pepe PE; EvK Clinical Trial Group. Measuring the cost and effect of current community consultation and public disclosure techniques in emergency care research. Resuscitation. 2018 Jul;128:37-42. doi: 10.1016/j.resuscitation.2018.04.033. Epub 2018 Apr 30.
PubMed 29715485Matchett G, Gasanova I, Riccio CA, Nasir D, Sunna MC, Bravenec BJ, Azizad O, Farrell B, Minhajuddin A, Stewart JW, Liang LW, Moon TS, Fox PE, Ebeling CG, Smith MN, Trousdale D, Ogunnaike BO; EvK Clinical Trial Collaborators. Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial. Intensive Care Med. 2022 Jan;48(1):78-91. doi: 10.1007/s00134-021-06577-x. Epub 2021 Dec 14.
PubMed 34904190
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02643381
- Acronym / sponsor ID
- EvK / 022015-023
- Conditions
- Cardiopulmonary Arrest, Respiratory Arrest
- Keywords
- etomidate, ketamine, endotracheal intubation, anesthesia induction medications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.
Detailed description
Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.
The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.
Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Experimental | Drug: Etomidate, Procedure: Emergency Endotracheal Intubation, Device: Mechanical VentilationPatients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. |
| Ketamine | Experimental | Drug: Ketamine, Procedure: Emergency Endotracheal Intubation, Device: Mechanical VentilationPatients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient (male or female) requiring emergency endotracheal intubation.
Key exclusion criteria (6 listed)
- Children (<18 years old).
- Women who are known to be pregnant.
- Any patient who has been previously randomized in the EvK Trial.
- Patients who require endotracheal intubation without sedative medication. For example, patients in full cardiac arrest.
- Patients with a known allergy to ketamine or etomidate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidatePatients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. | Drug | Etomidate |
| KetaminePatients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. | Drug | Ketamine |
| Emergency Endotracheal IntubationPatients 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. | Procedure or surgery | Etomidate, Ketamine |
| Mechanical VentilationPatients 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. | Device | Etomidate, Ketamine |
Primary outcome
Survival at Day 7
Time frame: Day 7
Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation
7 secondary outcomes
Survival at Day 28
Time frame: Day 28
Sequential Organ Failure Assessment (SOFA) Scores
Time frame: Day 1, Day 2, Day 3, Day 4
Duration of Mechanical Ventilation
Time frame: From time of documented insertion until the time of documented removal, assessed up to 28 days
Duration of Catecholamine Therapy
Time frame: From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
Length of Stay in ICU
Time frame: Assessed up to 28 days
Number of Participants With New Diagnosis of Adrenal Insufficiency
Time frame: Day 28
Number of Attempts Necessary to Intubate
Time frame: Immediate (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29715485Matchett G, Ryan TJ, Sunna MC, Lee SC, Pepe PE; EvK Clinical Trial Group. Measuring the cost and effect of current community consultation and public disclosure techniques in emergency care research. Resuscitation. 2018 Jul;128:37-42. doi: 10.1016/j.resuscitation.2018.04.033. Epub 2018 Apr 30.
- Derived from this study: PubMed 34904190Matchett G, Gasanova I, Riccio CA, Nasir D, Sunna MC, Bravenec BJ, Azizad O, Farrell B, Minhajuddin A, Stewart JW, Liang LW, Moon TS, Fox PE, Ebeling CG, Smith MN, Trousdale D, Ogunnaike BO; EvK Clinical Trial Collaborators. Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial. Intensive Care Med. 2022 Jan;48(1):78-91. doi: 10.1007/s00134-021-06577-x. Epub 2021 Dec 14.
- Individual participant dataSharing planned: No. Aggregate anonymous data will be published in accord with our IRB approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Matchett, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate, Ketamine and Emergency Endotracheal Intubation in people with Cardiopulmonary Arrest and Respiratory Arrest, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.