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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01823328
Other study ID # HSR 13-3601
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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