Ketamine Versus Etomidate for Rapid Sequence Intubation

• ClinicalTrials.gov Identifier: NCT01823328
• Recruitment Status: Completed
• First Posted: April 4, 2013
• Results First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Sponsor: Hennepin Healthcare Research Institute
• Information provided by (Responsible Party): Hennepin Healthcare Research Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Airway Control; Anesthesia; Intubation; Complication	Drug: Ketamine; Drug: Etomidate	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
• Study Start Date: September 2013
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ketamine; Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).	Drug: Ketamine; Subjects will receive ketamine for sedation prior to rapid sequence intubation.; Other Names: Ketanest; Ketaset; Ketalar
Active Comparator: Etomidate; Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).	Drug: Etomidate; Subjects will receive etomidate for sedation prior to rapid sequence intubation.; Other Name: Amidate

Outcome Measures

Primary Outcome Measures :

1. SOFA Score [ Time Frame: 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 Outcome Measures :

1. Mortality in Sepsis and Septic Shock [ Time Frame: 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

2. Number of Patients With First-pass Success [ Time Frame: 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.
3. Doses of Post-intubation Sedation [ Time Frame: 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.
4. Number of Patients With Post-intubation Hypoxemia [ Time Frame: 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.

5. Number of Patients With Hypotension [ Time Frame: 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

6. Peak and Plateau Pressure [ Time Frame: 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.
7. Mortality [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

Hennepin Healthcare Research Institute

Investigators

• Principal Investigator: Brian E Driver, MD; Hennepin County Medical Canter

More Information

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT01823328
• Other Study ID Numbers: HSR 13-3601
• First Posted: April 4, 2013
• Results First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Keywords provided by Hennepin Healthcare Research Institute:

Intubation; Airway; Emergent intubation; Rapid sequence intubation; Rapid sequence induction; RSI; Ketamine; Etomidate; Sepsis; Sedative; Sedation

Additional relevant MeSH terms:

Ketamine; Etomidate; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hypnotics and Sedatives