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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:
Information provided by:
St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier:
NCT00248729
First received: November 2, 2005
Last updated: August 28, 2006
Last verified: November 2005

November 2, 2005
August 28, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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.

Both
18 Years and older
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