Pre-hospital Hypoxemia in Trauma Patients

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

Study Description

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

Study Design

• 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

Groups and Cohorts

Group/Cohort
Written standard of care
Usual practice pattern

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Jason T McMullan, MD; University of Cincinnati

More Information

• 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
• 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:

Hypoxia; Wounds and Injuries; Signs and Symptoms, Respiratory