Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study

Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ALI is unknown. The investigators hypothesize that mechanical ventilation is frequently used in the ED and for a variety of reasons, and that ED mechanical ventilation has an effect on long term outcomes.

Study Overview

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Medicine
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the emergency department requiring invasive mechanical ventilation.

Description

Inclusion Criteria:

  • Ventilation either via an endotracheal tube or tracheostomy

Exclusion Criteria:

  • Non-invasive positive pressure ventilation;
  • Death in the immediate post-intubation phase of care;
  • Chronic ventilator-dependence, either at home or extended care facility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All ED patients requiring mechanical ventilation
Mechanical ventilation via an endotracheal tube or tracheostomy tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Further Characterize ED Mechanical Ventilation
Time Frame: 1 month
In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS
Time Frame: 1 month
Development of ARDS after admission to the hospital
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brian M Fuller, MD, Washington University School of Medicine in St. Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Failure

Clinical Trials on For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.

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