- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074983
Pre-hospital Hypoxemia in Trauma Patients
Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?
Study Overview
Status
Conditions
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:
- 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
- Identify the proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
- 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)
- Determine the amount of oxygen (Liters per minute) required to reverse hypoxemia
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267
- University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Written standard of care
|
Usual practice pattern
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
Time Frame: at enrollment
|
at enrollment
|
Amount of oxygen required to correct hypoxemia
Time Frame: at enrollment
|
at enrollment
|
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
|
at study conclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason T McMullan, MD, University of Cincinnati
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FA8650-05-2-6518-661150
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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