Registry of Emergency Airways Arriving at Combat Hospitals (REACH)

May 12, 2017 updated by: William Beaumont Army Medical Center

Registry of Emergency Airways Arriving at Combat Hospitals (REACH)

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Study Population

battlefield casualties who received advanced pre-hospital airway on the battlefield

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bruce D Adams, MD, William Beaumont Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • C.2005.055et

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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