Pre-hospital Hypoxemia in Trauma Patients

NCT ID: NCT01074983

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-02-29

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

Conditions

Trauma

Keywords

Prehospital, Oxygen, Trauma, Hypoxemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Written standard of care

No interventions assigned to this group

Usual practice pattern

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jason McMullan

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason T McMullan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

FA8650-05-2-6518-661150

Identifier Type: -

Identifier Source: org_study_id