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The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Active Comparator | Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). |
|
| Etomidate | Active Comparator | Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Subjects will receive ketamine for sedation prior to rapid sequence intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian E Driver, MD | Hennepin County Medical Canter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
14 patients withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation. |
| FG001 | Etomidate | Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation. |
| BG001 | Etomidate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | up to 3 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypertension | Cardiac disorders | Systematic Assessment | After ketamine administration one patient had severely elevated blood pressure > 200/100 mm Hg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Audrey Hendrickson | Hennepin Healthcare | 612-873-9528 | Audrey.Hendrickson@hcmed.org |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005045 | Etomidate |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Etomidate | Drug | Subjects will receive etomidate for sedation prior to rapid sequence intubation. |
|
|
| 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. | 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. | up to 6 hours |
| Number of Patients With Post-intubation Hypoxemia | The following will be compared between the two groups:
Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more. | up to 2 hours |
| Number of Patients With Hypotension | The following will be compared between the two groups:
Hypotension is defined as a systolic blood pressure less than 90 mm Hg | 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. | 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). | 30 Days or Discharge |
Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).
Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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:
Septic shock: defined as sepsis plus either: 1) Systolic blood pressure <90 after 1L of intravenous fluid or 2) lactate >=4mmol/L | Subgroup of those with sepsis | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 5 minutes (average time frame) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | bolus doses of sedation | up to 6 hours |
|
|
|
| Secondary | Number of Patients With Post-intubation Hypoxemia | The following will be compared between the two groups:
Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more. | Those with oxygen saturation data | Posted | Count of Participants | Participants | up to 2 hours |
|
|
|
| Secondary | Number of Patients With Hypotension | The following will be compared between the two groups:
Hypotension is defined as a systolic blood pressure less than 90 mm Hg | Posted | Count of Participants | Participants | up to 6 hours |
|
|
|
| Secondary | 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. | Those with peak and plateau pressure available | Posted | Median | Inter-Quartile Range | cm water | up to 30 minutes (average time frame) |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 30 Days or Discharge |
|
|
|
| 1 |
| 62 |
| 0 |
| 62 |
| EG001 | Etomidate | Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation. | 0 | 67 | 0 | 67 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |