- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628523
Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
March 9, 2020 updated by: Washington University School of Medicine
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
Status
Completed
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
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201205165
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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