Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etomidate (20mg) or Midazolam (7mg)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
Eligibility 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.
Sites / Locations
- St. Luke's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00248729
First Posted
November 2, 2005
Last Updated
August 28, 2006
Sponsor
St. Luke's Hospital, Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00248729
Brief Title
Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
Official Title
Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's Hospital, Pennsylvania
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etomidate (20mg) or Midazolam (7mg)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne L Jacoby, MD
Organizational Affiliation
St. Luke's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
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