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

NCT01628523 | Completed Results

• 1 other identifier: 201205165
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Respiratory Failure; Mechanical Ventilation; Acute Lung Injury

Keywords

Respiratory failure; Mechanical ventilation; Acute lung injury

Outcome Measures

Primary Outcomes (1)

• To Further Characterize ED Mechanical Ventilation

  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 Outcomes (1)

• The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS

  1 month

Study Arms (1)

All ED patients requiring mechanical ventilation

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

Interventions

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

Mechanical ventilation via an endotracheal tube or tracheostomy tube

All ED patients requiring mechanical ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department requiring invasive mechanical ventilation.

You may qualify if:

• Ventilation either via an endotracheal tube or tracheostomy

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Iowa: collaborator
• Christiana Care Health Services: collaborator
• University of Cincinnati: collaborator

Study Sites (4)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

University of Iowa College of Medicine

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Location

Related Publications (1)

• Fuller BM, Mohr NM, Miller CN, Deitchman AR, Levine BJ, Castagno N, Hassebroek EC, Dhedhi A, Scott-Wittenborn N, Grace E, Lehew C, Kollef MH. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study. Chest. 2015 Aug;148(2):365-374. doi: 10.1378/chest.14-2476.

  PMID: 25742126 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Acute Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Injury; Lung Diseases

Limitations and Caveats

This was an observational study, so only associations (and not causation) can be concluded from the data.

Results Point of Contact

• Title: Brian M Fuller
• Organization: Washington University in St. Louis

fullerb@wusm.wustl.edu

3147475368

Study Officials

• Brian M Fuller, MD

  Washington University School of Medicine in St. Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 26, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (4)