TraumaREACHNCT01405001
Registry of Emergency Airways Arriving at Combat Hospitals
An observational study of Trauma and Wounds and Injuries, run by William Beaumont Army Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Wounds and Injuries, Emergencies
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: battlefield casualties who received advanced pre-hospital airway on the battlefield
Who may be able to join
- Casualties presenting to the Combat Support Hospital (CSH) who received advanced prehospital airway on the battlefield.
Who cannot join
- Casualties who received the initial advanced prehospital airway at the Combat Support Hospital (CSH).
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Wounds and Injuries, Emergencies
- Keywords
- Emergencies, War, Intubation, Intratracheal
- Medical subject headings
- Wounds and Injuries, Emergencies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startDec 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Beaumont Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Bruce D Adams, MD, Principal investigator, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405001
- Sponsor's protocol ID
- C.2005.055et
- Acronym
- REACH
- Status last verified
- May 2017
- First submitted
- 27 Jul 2011
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Emergency Airways Arriving at Combat Hospitals (REACH)
- ClinicalTrials.gov ID
- NCT01405001
- Acronym / sponsor ID
- REACH / C.2005.055et
- Conditions
- Trauma, Wounds and Injuries, Emergencies
- Keywords
- Emergencies, War, Intubation, Intratracheal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- William Beaumont Army Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Dec 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- battlefield casualties who received advanced pre-hospital airway on the battlefield
Key inclusion criteria (1 listed)
- Casualties presenting to the Combat Support Hospital (CSH) who received advanced prehospital airway on the battlefield.
Key exclusion criteria (1 listed)
- Casualties who received the initial advanced prehospital airway at the Combat Support Hospital (CSH).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce D Adams, MD principal investigator
William Beaumont Army Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Wounds and Injuries, run by William Beaumont Army Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.