Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
Information source: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Failure
Intervention: Etomidate (20mg) or Midazolam (7mg) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: St. Luke's Hospital, Pennsylvania Official(s) and/or principal investigator(s): Jeanne L Jacoby, MD, Principal Investigator, Affiliation: St Luke's Hospital
Summary
The objective of this study was to compare the utility of etomidate and midazolam in helping
patients to relax when there was a need for the placement of a ventilation tube by medics
who were transporting patients to a hospital in an ambulance.
Clinical Details
Official title: Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed description:
Study Objective: The objective of this study was to compare the utility of etomidate and
midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital
adult patients.
Methods: This prospective, double-blind, randomized trial was conducted with two ground
pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by
the two participating systems requiring pre-hospital SFI were eligible for participation.
The ambulances were stocked with blinded numbered syringes, each containing either 7mg of
midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required
and no paralytics were used. If sedation was not achieved with the study drug, medics could
request additional sedation from a Medical command physician; only midazolam or diazepam
were available outside of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Under the study protocol, all patients age 18 or over transported by the two participating
ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for
participation.
Exclusion Criteria:
Exclusion criteria were pregnancy and age less than 18.
Locations and Contacts
St. Luke's Hospital, Bethlehem, Pennsylvania 18015, United States
Additional Information
Starting date: October 2002
Last updated: August 28, 2006
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