Clinical trial NCT01823328: Ketamine Versus Etomidate for Rapid Sequence Intubation
Official title: Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Airway Control
Anesthesia
Intubation
Complication
Keywords: Intubation
Airway
Emergent intubation
Rapid sequence intubation
Rapid sequence induction
RSI
Ketamine
Etomidate
Sepsis
Sedative
Sedation
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: SOFA Score
timeFrame: up to 3 days
Secondary outcomes:
measure: Mortality in Sepsis and Septic Shock
timeFrame: 30 Days
measure: Number of Patients With First-pass Success
timeFrame: up to 5 minutes (average time frame)
measure: Doses of Post-intubation Sedation
timeFrame: up to 6 hours
measure: Number of Patients With Post-intubation Hypoxemia
timeFrame: up to 2 hours
measure: Number of Patients With Hypotension
timeFrame: up to 6 hours
measure: Peak and Plateau Pressure
timeFrame: up to 30 minutes (average time frame)
measure: Mortality
timeFrame: 30 Days or Discharge
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Canter
name: Brian E Driver, MD
role: PRINCIPAL_INVESTIGATOR
References: