Pre-hospital Hypoxemia in Trauma Patients
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|
|
Trauma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen? |
- 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 ] [ Designated as safety issue: No ]
- Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
- Amount of oxygen required to correct hypoxemia [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Written standard of care |
| Usual practice pattern |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Trauma patients arriving at a Level 1 Trauma Center by designated EMS units
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
Contacts and Locations| United States, Ohio | |
| University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Principal Investigator: | Jason T McMullan, MD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Jason McMullan, MD, University of Cincinnati Department of Emergency Medicine |
| ClinicalTrials.gov Identifier: | NCT01074983 History of Changes |
| Other Study ID Numbers: | FA8650-05-2-6518-661150 |
| Study First Received: | February 23, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Cincinnati:
|
Prehospital, Oxygen, Trauma, Hypoxemia |
Additional relevant MeSH terms:
|
Wounds and Injuries Anoxia Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013