Clinical trial NCT01074983: Pre-hospital Hypoxemia in Trauma Patients
Official title: Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Prehospital, Oxygen, Trauma, Hypoxemia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2010-02-24
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients arriving at a Level 1 Trauma Center by designated EMS units

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.

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: At enrollment
Secondary outcomes:
measure: Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
timeFrame: at enrollment
measure: Amount of oxygen required to correct hypoxemia
timeFrame: at enrollment
measure: Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units
timeFrame: at study conclusion
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jason T McMullan, MD
role: PRINCIPAL_INVESTIGATOR
References: