Ketamine Versus Etomidate for Rapid Sequence Intubation

Anesthesia Clinical Trial

Official title:

Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823328
• Other study ID #: HSR 13-3601
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2019
• Source: Hennepin Healthcare Research Institute.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Control
• Anesthesia
• Complication
• Intubation

Intervention

Drug:
• Ketamine
Subjects will receive ketamine for sedation prior to rapid sequence intubation.
• Etomidate
Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 3 days
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: Temperature >38C or <36C; Respiratory Rate >20 or PaCO2 <32 mmHg; Heart Rate >90; 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	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.	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.	up to 6 hours
Secondary	Number of Patients With Post-intubation Hypoxemia	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.	up to 2 hours
Secondary	Number of Patients With Hypotension	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	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.	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).	30 Days or Discharge