Skip to main content
OpenTrials
Completed

NCT Number: NCT01074983

Pre-hospital Hypoxemia in Trauma Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Cincinnati, Ohio, 45267, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 24, 2010
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.