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

Respiratory Failure Clinical Trial

Official title:

Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248729
• Other study ID #: SLHN 001
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2005
• Last updated: August 28, 2006
• Start date: October 2002
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: St. Luke's Hospital, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Etomidate (20mg) or Midazolam (7mg)

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States,