Intubation Complication
Conditions
Keywords
Rapid Sequence Intubation, Hemodynamics, Etomidate, Ketamine
Brief summary
The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.
Detailed description
This is a randomized prospective study evaluating the hemodynamic response in adult participants greater than or equal to 18 years of age undergoing RSI in the pre-hospital or emergency department setting. Hemodynamic response is the cardiology response of the circulatory system. The investigators will compare the drugs Ketamine and Etomidate in participants having RSI. Ketamine and Etomidate are immediately available for RSI in both settings as both are currently standards of care for RSI. Research thus far demonstrates that both Etomidate and ketamine are safe and effective for RSI. Despite the reported safety of Ketamine, Etomidate usage continues to far surpass that of ketamine. Both Etomidate and Ketamine are FDA-approved for induction of anesthesia. They are both ideal drugs for intubation due to their pharmacokinetic properties including a quick onset of less than 60 seconds, a short duration of about 10 minutes, and the minimal effect they have on the cardiovascular system. The neutral effect on the cardiovascular system is particularly important in the acute and traumatic setting when patients are often hypotensive. However, there are some differences and disadvantages in the two medications. Due to these factors and limited data to support Ketamine as an equal or superior alternative to Etomidate, it has been difficult to clearly recommend one agent over the other for RSI. Data will be analyzed using SPSS with a p-value of less than 0.05 being considered significant. The PI will consider a 20% decrease in systolic BP from a participant baseline as significant, and will compare the incidence of post RSI hypotension between the two groups. Several a priori subgroups will be evaluated to include patients greater than 70 years of age, trauma participants requiring RSI, and those participants whose shock index is less than 0.9 versus those whose shock index is greater than 0.9. To maintain 80% power with a probability of 0.05, 200 participants will be needed in each arm to detect at 25% difference in SBP (baseline to post drug administration effects)
Interventions
DRUGEtomidate
Etomidate will be administered as the sedative for RSI on even days
DRUGKetamine
Ketamine will be administered as the sedative for RSI on odd days
Sponsors
New Hanover Regional Medical Center
South East Area Health Education Center, Wilmington, NC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons greater than 18yrs requiring rapid sequence intubation for any reason.
Exclusion criteria
* Pregnant patients * Children under the age of 18 * Patients with a known hypersensitivity to etomidate or ketamine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug. | The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited if they required rapid sequence intubation in the pre-hospital or 17th street campus emergency department setting between January 1, 2018 and July 30, 2019.
Pre-assignment details
98 did not meet inclusion criteria, 48 had incomplete sedative data, and 71 were excluded for other reasons
Participants by arm
| Arm | Count |
|---|---|
| Etomidate Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
Etomidate: Etomidate will be administered as the sedative for RSI on even days | 194 |
| Ketamine Ketamine will be dosed once at a standard 2 mg/kg via IV Push
Ketamine: Ketamine will be administered as the sedative for RSI on odd days | 204 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 14 | 16 |
Baseline characteristics
| Characteristic | Etomidate | Ketamine | Total |
|---|---|---|---|
| Age, Continuous | 57.48 years STANDARD_DEVIATION 19.5 | 56.68 years STANDARD_DEVIATION 19.68 | 57.08 years STANDARD_DEVIATION 19.57 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 67 Participants | 74 Participants | 141 Participants |
| Sex: Female, Male Male | 127 Participants | 130 Participants | 257 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 194 | 0 / 204 |
| other Total, other adverse events | 117 / 194 | 111 / 204 |
| serious Total, serious adverse events | 0 / 194 | 1 / 204 |
Outcome results
Primary
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI
The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.
Time frame: The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etomidate | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Pre-SBP | 138.04 mmHg | Standard Deviation 38.63 |
| Etomidate | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Post SBP 8-15 | 130.42 mmHg | Standard Deviation 42.19 |
| Etomidate | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Post SBP 0-7 | 139.09 mmHg | Standard Deviation 44.52 |
| Ketamine | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Pre-SBP | 132.39 mmHg | Standard Deviation 39.54 |
| Ketamine | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Post SBP 0-7 | 130.09 mmHg | Standard Deviation 41.78 |
| Ketamine | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | Post SBP 8-15 | 120.80 mmHg | Standard Deviation 37.37 |