Pre-hospital Hypoxemia in Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Henry M Jackson Foundation
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01074983
First received: February 23, 2010
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

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
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
  • Amount of oxygen required to correct hypoxemia [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Written standard of care
Usual practice pattern

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074983

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Henry M Jackson Foundation
Investigators
Principal Investigator: Jason T McMullan, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Jason McMullan, MD, University of Cincinnati Department of Emergency Medicine
ClinicalTrials.gov Identifier: NCT01074983     History of Changes
Other Study ID Numbers: FA8650-05-2-6518-661150
Study First Received: February 23, 2010
Last Updated: March 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Prehospital, Oxygen, Trauma, Hypoxemia

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014