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Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248729
First Posted: November 4, 2005
Last Update Posted: August 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Luke's Hospital, Pennsylvania
November 2, 2005
November 4, 2005
August 29, 2006
October 2002
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Complete list of historical versions of study NCT00248729 on ClinicalTrials.gov Archive Site
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Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Respiratory Failure
Drug: Etomidate (20mg) or Midazolam (7mg)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2005
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00248729
SLHN 001
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St. Luke's Hospital, Pennsylvania
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Principal Investigator: Jeanne L Jacoby, MD St. Luke's Hospital
St. Luke's Hospital, Pennsylvania
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP