Trial · NCT01823328
Ketamine Versus Etomidate for Rapid Sequence Intubation
NCT01823328, Phase 4, Completed, Hennepin Healthcare Research Institute; results first posted 2019-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine Versus Etomidate for Rapid Sequence Intubation. Trials, record NCT01823328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01823328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine Versus Etomidate for Rapid Sequence Intubation
- NCT number
- NCT01823328
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 143 participants, actual
- Lead sponsor
- Hennepin Healthcare Research Institute
- Conditions
- Airway Control, Anesthesia, Intubation, Complication
- Interventions
- Ketamine, Etomidate
- First posted
- 2013-04-04
- Last updated
- 2019-05-24
- Results first posted
- 2019-05-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SOFA Score | 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. |
| Secondary | Mortality in Sepsis and Septic Shock | 30 Days | 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 |
| Secondary | Number of Patients With First-pass Success | up to 5 minutes (average time frame) | 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. |
| Secondary | Doses of Post-intubation Sedation | up to 6 hours | 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. |
| Secondary | Number of Patients With Post-intubation Hypoxemia | up to 2 hours | 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. |
| Secondary | Number of Patients With Hypotension | up to 6 hours | 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 |
| Secondary | Peak and Plateau Pressure | up to 30 minutes (average time frame) | 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. |
| Secondary | Mortality | 30 Days or Discharge | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SOFA Score | up to 3 days | units on a scale | MEDIAN | |
| SECONDARY | Mortality in Sepsis and Septic Shock | 30 Days | Subgroup of those with sepsis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With First-pass Success | up to 5 minutes (average time frame) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Doses of Post-intubation Sedation | up to 6 hours | bolus doses of sedation | MEDIAN | |
| SECONDARY | Number of Patients With Post-intubation Hypoxemia | up to 2 hours | Those with oxygen saturation data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Hypotension | up to 6 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Peak and Plateau Pressure | up to 30 minutes (average time frame) | Those with peak and plateau pressure available | cm water | MEDIAN |
| SECONDARY | Mortality | 30 Days or Discharge | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SOFA Score | Ketamine | 6.5 | Inter-Quartile Range 5 to 9 | units on a scale | |
| SOFA Score | Etomidate | 7 | Inter-Quartile Range 5 to 9 | units on a scale | |
| Mortality in Sepsis and Septic Shock | Ketamine | 1 | Participants | ||
| Mortality in Sepsis and Septic Shock | Etomidate | 4 | Participants | ||
| Number of Patients With First-pass Success | Ketamine | 59 | Participants | ||
| Number of Patients With First-pass Success | Etomidate | 60 | Participants | ||
| Doses of Post-intubation Sedation | Ketamine | 1 | Inter-Quartile Range 0 to 2 | bolus doses of sedation | |
| Doses of Post-intubation Sedation | Etomidate | 1 | Inter-Quartile Range 0 to 2 | bolus doses of sedation | |
| Number of Patients With Post-intubation Hypoxemia | Ketamine | Peri-intubation hypoxemia | 8 | Participants | |
| Number of Patients With Post-intubation Hypoxemia | Etomidate | Peri-intubation hypoxemia | 13 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketamine | 70 | |
| Overall Study | STARTED | Etomidate | 73 | |
| Overall Study | COMPLETED | Ketamine | 62 | |
| Overall Study | COMPLETED | Etomidate | 67 | |
| Overall Study | NOT COMPLETED | Ketamine | 8 | |
| Overall Study | NOT COMPLETED | Etomidate | 6 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Severe hypertension | Cardiac disorders | Ketamine | 1 | 62 | 1 |
| serious | Severe hypertension | Cardiac disorders | Etomidate | 0 | 67 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine | ||
| Total, all-cause mortality | Etomidate | ||
| Total, other adverse events | Ketamine | 0 | 62 |
| Total, other adverse events | Etomidate | 0 | 67 |
| Total, serious adverse events | Ketamine | 1 | 62 |
| Total, serious adverse events | Etomidate | 0 | 67 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketamine vs Etomidate: Mortality | Trial comparisons |
| Ketamine vs Etomidate: Number of Patients With First-pass Success | Trial comparisons |
| Ketamine vs Etomidate: Mortality in Sepsis and Septic Shock | Trial comparisons |
| Ketamine vs Etomidate: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01823328
GET https://conductscience.org/api/trials/v1/NCT01823328/results?page=2