Airway ControlPhase 4NCT01823328
Ketamine Versus Etomidate for Rapid Sequence Intubation
A Phase 4 study testing Ketamine and Etomidate in people with Airway Control and Anesthesia, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Control, Anesthesia, Intubation
- What is being tested?
- Ketamine and Etomidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2015
- 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
- 18 years of age
- Undergoing rapid sequence intubation (RSI) in the Emergency Department
Who cannot join
- Known contraindication to ketamine or etomidate
- Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
- Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
- Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
- Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
Read the detailed description
This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.
- Conditions
- Airway Control, Anesthesia, Intubation, Complication
- Being tested
- Ketamine, Etomidate
- Keywords
- Intubation, Airway, Emergent intubation, Rapid sequence intubation, Rapid sequence induction, RSI, Ketamine, Etomidate, Sepsis, Sedative, Sedation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketanest, Ketaset, Ketalar
Subjects will receive ketamine for sedation prior to rapid sequence intubation.
EtomidateDrug
Also called Amidate
Subjects will receive etomidate for sedation prior to rapid sequence intubation.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). Receives: Drug: Ketamine |
| Etomidate | Active comparator | Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). Receives: Drug: Etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA Score
*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
Measured: up to 3 days
Secondary outcomes (7)
Mortality in Sepsis and Septic Shock
Evaluate mortality for the sub-group diagnosed with sepsis and septic shock, defined as:
- Suspected infection, and at least 2 of 4 systemic inflammatory response syndrome (SIRS) criteria:
- Temperature >38C or <36C
- Respiratory Rate >20 or PaCO2 <32 mmHg
- Heart Rate >90
- White blood cell count >12,000 or <4,000, or > 10% bands
Septic shock:
defined as sepsis plus either: 1) Systolic blood pressure <90 after 1L of intravenous fluid or 2) lactate >=4mmol/L
Measured: 30 Days
Number of Patients With First-pass Success
The rate of first pass success, defined as successful tracheal intubation on the first attempt. An attempt is defined as the insertion and subsequent removal of the laryngoscopic device from the patient's mouth, regardless of whether an endotracheal tube was inserted.
Measured: up to 5 minutes (average time frame)
Doses of Post-intubation Sedation
The number of bolus doses of sedative administered post-intubation will be compared up to 6 hours (including morphine, dexmedetomidine, propofol , etomidate, ketamine, lorazepam (Ativan), midazolam (Versed), diazepam (Valium), fentanyl, hydromorphone (Dilaudid)). Infusions of these medications will be recorded separately but will not be part of this outcome.
Measured: up to 6 hours
Number of Patients With Post-intubation Hypoxemia
The following will be compared between the two groups:
- Hypoxemia and severe hypoxemia in the peri-intubation period. Peri-intubation hypoxemia was defined as during after the 5 minutes immediately after intubation.
- Hypoxemia within the first 2 hours intubation
Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more.
Measured: up to 2 hours
Number of Patients With Hypotension
The following will be compared between the two groups:
- Hypotension in the ED post-intubation
- Hypotension within the first 6 hours of the hospital stay, including time spent in the ED
Hypotension is defined as a systolic blood pressure less than 90 mm Hg
Measured: up to 6 hours
Peak and Plateau Pressure
The Peak and plateau pressures will be compared between the two groups, with a pre-defined subgroup analysis of patients who are being intubated for severe asthma and chronic obstructive pulmonary disease (COPD). The ventilator was used to measure these values.
Measured: up to 30 minutes (average time frame)
Mortality
Mortality will be assessed at 30 days or at discharge from the hospital, whichever occurs first. This study is not powered to detect a significant difference in mortality, however; this will primarily be a safety study comparing the use ketamine versus etomidate as sedative agents for rapid sequence intubation (RSI) in the Emergency Department (ED).
Measured: 30 Days or Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionOct 2015
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.
- Other trials for Airway ControlStudies of the same condition, open and under way.
- 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian E Driver, MD, Principal investigator, Hennepin County Medical Canter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823328
- Sponsor's protocol ID
- HSR 13-3601
- Status last verified
- May 2019
- First submitted
- 28 Mar 2013
- Last updated
- 24 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
- ClinicalTrials.gov ID
- NCT01823328
- Acronym / sponsor ID
- HSR 13-3601
- Conditions
- Airway Control, Anesthesia, Intubation, Complication
- Keywords
- Intubation, Airway, Emergent intubation, Rapid sequence intubation, Rapid sequence induction, RSI, Ketamine, Etomidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 24 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
Detailed description
This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineSubjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). |
| Etomidate | Active comparator | Drug: EtomidateSubjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Undergoing rapid sequence intubation (RSI) in the Emergency Department
Key exclusion criteria (6 listed)
- Known contraindication to ketamine or etomidate
- Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
- Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
- Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
- Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
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 |
|---|---|---|
| KetamineAlso: Ketanest, Ketaset, KetalarSubjects will receive ketamine for sedation prior to rapid sequence intubation. | Drug | Ketamine |
| EtomidateAlso: AmidateSubjects will receive etomidate for sedation prior to rapid sequence intubation. | Drug | Etomidate |
Primary outcome
SOFA Score
Time frame: up to 3 days
*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
7 secondary outcomes
Mortality in Sepsis and Septic Shock
Time frame: 30 Days
Number of Patients With First-pass Success
Time frame: up to 5 minutes (average time frame)
Doses of Post-intubation Sedation
Time frame: up to 6 hours
Number of Patients With Post-intubation Hypoxemia
Time frame: up to 2 hours
Number of Patients With Hypotension
Time frame: up to 6 hours
Peak and Plateau Pressure
Time frame: up to 30 minutes (average time frame)
Mortality
Time frame: 30 Days or Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian E Driver, MD principal investigator
Hennepin County Medical Canter
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 Ketamine and Etomidate in people with Airway Control and Anesthesia, run by Hennepin Healthcare Research Institute 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 2 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 24 May 2019. 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 24 May 2019). 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?
SOFA Score (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.