Pre-hospital Hypoxemia in Trauma Patients

Trauma Clinical Trial

Official title:

Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074983
• Other study ID #: FA8650-05-2-6518-661150
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: December 8, 2015
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Henry M. Jackson Foundation for the Advancement of Military Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At enrollment	No
Secondary	Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting		at enrollment	No
Secondary	Amount of oxygen required to correct hypoxemia		at enrollment	No
Secondary	Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units		at study conclusion	No