ED Lung Protective Ventilation to Reduce Complications

May 4, 2018 updated by: Brian Fuller, Washington University School of Medicine

The Effect of Lung Protective Ventilation Initiated in the Emergency Department on the Incidence of Pulmonary Complications and Clinical Outcomes

Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.

Study Type

Observational

Enrollment (Actual)

1705

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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washinton University School of Medicine in St. Louis

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

mechanically ventilated patients in the emergency department

Description

Inclusion Criteria:

  • mechanically ventilated via an endotracheal tube in the ED

Exclusion Criteria:

  • death in the ED,
  • death or discontinuation of ventilation within 24 hours,
  • chronic mechanical ventilation,
  • ARDS while in the ED
  • transfer to another hospital.

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
Pre-intervention group
mechanically ventilated patients before implementation of ED lung protective ventilation
Intervention group
mechanically ventilated patients after implementation of ED lung protective ventilation
Procedure: lung protective ventilation
Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients That Die During the Hospitalization
Time Frame: Patients will be followed for the duration of hospital stay
Patients will be followed for the duration of hospital stay

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Brian M Fuller, MD, MSCI, Washington University School of Medicine

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.

General Publications

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

October 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 201409024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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