Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
|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.|
|ClinicalTrials.gov Identifier: NCT00248729|
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : August 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure||Drug: Etomidate (20mg) or Midazolam (7mg)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Official Title:||Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial|
|Study Start Date :||October 2002|
|Study Completion Date :||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248729
|United States, Pennsylvania|
|St. Luke's Hospital|
|Bethlehem, Pennsylvania, United States, 18015|
|Principal Investigator:||Jeanne L Jacoby, MD||St. Luke's Hospital|