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Registry of Emergency Airways Arriving at Combat Hospitals (REACH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405001
First Posted: July 28, 2011
Last Update Posted: May 16, 2017
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.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
William Beaumont Army Medical Center
  Purpose
This represents the first prospective examination of advanced airway management under combat conditions. The findings will have a tremendous impact on both modern prehospital medical practice and on the treatment of our wounded Soldiers during the Global War on Terrorism.

Condition
Trauma Wounds and Injuries Emergencies

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Emergency Airways Arriving at Combat Hospitals (REACH)

Resource links provided by NLM:


Further study details as provided by William Beaumont Army Medical Center:

Enrollment: 292
Study Start Date: December 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Stabilizing trauma victims in the out-of-hospital setting often requires the critical intervention of definitive airway management. Prehospital airway management studies in the U.S. have demonstrated variable success with endotracheal intubations by paramedics, ranging from 75-94% in recent well designed studies. Initial prehospital airway efforts showed there was a significant improvement in patient outcome when endotracheal intubation was performed in the field. Yet, a recent review cited 14 studies that demonstrated either no difference or even a higher mortality noted among patients that received prehospital endotracheal intubation by a paramedic. Of note, all of these previous studies were performed in non-combat settings and involved only civilian paramedics.

There currently are no prospective studies in the literature involving prehospital combat advanced airway management. Furthermore, it is not even clear how commonly advanced airway procedures are performed on the modern battlefield. Data from Vietnam shows that 6% of the soldiers killed in action suffered isolated airway injuries. In the current Global War on Terror, an estimated 27% of wounds occur to the head, neck or airway structures. Military databases demonstrate that patients requiring emergency airway management before reaching a combat support hospital constitute 5 to 10% of the total combat casualty population, and that acute airway compromise is a significant cause of preventable traumatic death in modern warfare. During Operation Iraqi Freedom, approximately 10% of the 3600 trauma patients that reached his Combat Support Hospital (CSH) had airway compromise as the primary cause of death. This may represent a conservative estimate given that it is not clear how many patients with airway compromise died on the battlefield and were never transferred to the CSH. In today's world, these findings are important to civilian physicians as well because of the parallels between combat settings and other austere environments such as wilderness medicine, medical support for law enforcement, and managing mass casualty effects of terrorist attacks and weapons of mass destruction.

The purpose of this study was to evaluate advanced airway management performance by prehospital providers during Operation Iraqi Freedom. Our intentions were to provide a preliminary analysis of prehospital airway management within the combat setting, and identify means of improving outcomes associated with prehospital endotracheal intubations. Other points of interest included gaining insight into which providers were at risk for performing incorrect intubations; theorizing how endotracheal intubations could be improved in the combat setting; and comparing the rate of missed intubations to previous studies performed in civilian settings.

This was a prospective, observational study performed under combat conditions during Operation Iraqi Freedom. This study was approved by the U.S. Army Clinical Investigation Regulatory Office. The primary outcome was independently physician verified correct placement of endotracheal tubes by prehospital providers within the combat setting.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Study Population
battlefield casualties who received advanced pre-hospital airway on the battlefield
Criteria

Inclusion Criteria:

  • Casualties presenting to the Combat Support Hospital (CSH) who received advanced prehospital airway on the battlefield.

Exclusion Criteria:

  • Casualties who received the initial advanced prehospital airway at the Combat Support Hospital (CSH).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405001


Sponsors and Collaborators
William Beaumont Army Medical Center
United States Department of Defense
Investigators
Principal Investigator: Bruce D Adams, MD William Beaumont Army Medical Center
  More Information

Responsible Party: William Beaumont Army Medical Center
ClinicalTrials.gov Identifier: NCT01405001     History of Changes
Other Study ID Numbers: C.2005.055et
First Submitted: July 27, 2011
First Posted: July 28, 2011
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by William Beaumont Army Medical Center:
Emergencies
War
Intubation, Intratracheal

Additional relevant MeSH terms:
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes