NCT01074983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

February 23, 2010

Last Update Submit

December 8, 2015

Conditions

Trauma

Keywords

Prehospital, Oxygen, Trauma, Hypoxemia

Outcome Measures

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

    At enrollment

Secondary Outcomes (3)

  • Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting

    at enrollment

  • Amount of oxygen required to correct hypoxemia

    at enrollment

  • Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units

    at study conclusion

Study Arms (2)

Written standard of care

Usual practice pattern

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Trauma patients arriving at a Level 1 Trauma Center by designated EMS units

You may qualify if:

  • acute traumatic injury
  • transported directly to study hospital
  • meets at least one trauma consult/trauma stat criteria

You may not qualify if:

  • lack of continuous peripheral pulse oximetry data
  • age \<18 years
  • on prescribed home oxygen therapy prior to trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesHypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason T McMullan, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

US(1)