\*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.
Ketamine Versus Etomidate for Rapid Sequence Intubation
Brief Summary
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
Intervention / Treatment
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Ketamine (DRUG)Subjects will receive ketamine for sedation prior to rapid sequence intubation.
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Etomidate (DRUG)Subjects will receive etomidate for sedation prior to rapid sequence intubation.
Condition or Disease
- Airway Control
- Anesthesia
- Intubation
- Complication
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 143 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Sep 01, 2013 | |
|---|---|---|
| Primary Completion: | Oct 01, 2015 | ACTUAL |
| Completion Date: | Oct 01, 2015 | ACTUAL |
| Study First Posted: | Apr 04, 2013 | ESTIMATED |
| Results First Posted: | May 24, 2019 | ACTUAL |
| Last Updated: | May 02, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Hennepin Healthcare Research Institute
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
Participant Groups
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Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).
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Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 18 years of age
* Undergoing rapid sequence intubation (RSI) in the Emergency Department
Exclusion Criteria:
* 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
* 18 years of age
* Undergoing rapid sequence intubation (RSI) in the Emergency Department
Exclusion Criteria:
* 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
Primary Outcomes
Secondary Outcomes
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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: 1. Temperature \>38C or \<36C 2. Respiratory Rate \>20 or PaCO2 \<32 mmHg 3. Heart Rate \>90 4. 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
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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.
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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.
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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.
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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
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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.
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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).
More Details
| NCT Number: | NCT01823328 |
|---|---|
| Other IDs: | HSR 13-3601 |
| Study URL: | https://clinicaltrials.gov/study/NCT01823328 |
Last updated: Sep 29, 2023