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Pre-hospital Hypoxemia in Trauma Patients

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ClinicalTrials.gov Identifier: NCT01074983
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : December 10, 2015
Sponsor:
Collaborator:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
Jason McMullan, University of Cincinnati

Brief Summary:
The intent of this study is to describe the proportion of trauma patients requiring oxygen before hospital arrival, the amount of oxygen they require, and whether or not the oxygen is beneficial to outcomes.

Condition or disease
Trauma

Detailed Description:

Trauma patients in the United States frequently receive high-flow high-concentration supplemental oxygen in the pre-hospital setting, yet their physiologic need is rarely known. Providing oxygen to everyone regardless of need may seem straightforward, but the practice has extensive implications in logistically challenging areas such as a combat arena or mass casualty event, and is not supported by care guidelines. Indeed, too much oxygen can be harmful for some patients.1, 2 If it is the case, that not all trauma patients require oxygen, this would decrease the logistical burden of providing oxygen in the pre-hospital environment. No study has yet been performed that describes the proportion of patients requiring oxygen, the amount of oxygen they require, and whether or not oxygen is beneficial to outcomes. This prospective observational cohort investigation aims to bridge the knowledge gap surrounding the need and possible benefits or harms arising from oxygen therapy. In our Emergency Medical Services (EMS) systems, the written standard of care is to provide oxygen only to maintain oxygen saturation at 95% or when hemorrhagic shock or traumatic brain injury are suspected.3 We will observe patterns of oxygen treatment and outcome for patients treated according to this written standard of care, and compare this to the treatment and outcomes for patients transported by EMS units who continue their usual practice pattern.

Specifically, we aim to:

  1. Identify the proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial EMS contact
  2. Identify the proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
  3. Identify differences in clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units. These outcomes include requirement for advanced airway management, hospital and intensive care unit lengths of stay, and disposition (including in-hospital and 30-day mortality)
  4. Determine the amount of oxygen (Liters per minute) required to reverse hypoxemia

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?
Study Start Date : February 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Written standard of care
Usual practice pattern



Primary Outcome Measures :
  1. Proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial emergency medical services (EMS) contact [ Time Frame: At enrollment ]

Secondary Outcome Measures :
  1. Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting [ Time Frame: at enrollment ]
  2. Amount of oxygen required to correct hypoxemia [ Time Frame: at enrollment ]
  3. Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units [ Time Frame: at study conclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Trauma patients arriving at a Level 1 Trauma Center by designated EMS units
Criteria

Inclusion Criteria:

  • acute traumatic injury
  • transported directly to study hospital
  • meets at least one trauma consult/trauma stat criteria

Exclusion Criteria:

  • lack of continuous peripheral pulse oximetry data
  • age <18 years
  • on prescribed home oxygen therapy prior to trauma

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): NCT01074983


Locations
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United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
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Principal Investigator: Jason T McMullan, MD University of Cincinnati
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Responsible Party: Jason McMullan, Associate Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01074983    
Other Study ID Numbers: FA8650-05-2-6518-661150
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Jason McMullan, University of Cincinnati:
Prehospital, Oxygen, Trauma, Hypoxemia
Additional relevant MeSH terms:
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Hypoxia
Wounds and Injuries
Signs and Symptoms, Respiratory