Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
This study is currently recruiting participants.
Verified February 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Collaborators:
University of Iowa
Indiana University School of Medicine
Christiana Care Health System
University of Cincinnati
Information provided by (Responsible Party):
Brian Fuller, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01628523
First received: June 20, 2012
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Failure Mechanical Ventilation Acute Lung Injury |
Other: For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube. |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- The epidemiology and incidence of mechanical ventilation in critically ill ED patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.
Secondary Outcome Measures:
- The incidence of acute lung injury in mechanically ventilated emergency department patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
Mechanical ventilation via an endotracheal tube or tracheostomy tube
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients presenting to the emergency department requiring invasive mechanical ventilation.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628523
Contacts
| Contact: Brian M Fuller, MD | 3147475368 | fullerb@wusm.wustl.edu |
Locations
| United States, Delaware | |
| Christiana Care Health System | Recruiting |
| Newark, Delaware, United States, 19718 | |
| Contact: Andrew Deitchman, MD ardeitchman@gmail.com | |
| Principal Investigator: Andrew Deitchman, MD | |
| United States, Indiana | |
| Indiana University School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Tim Ellender, MD tellende@iupui.edu | |
| Principal Investigator: Tim Ellender, MD | |
| United States, Iowa | |
| University of Iowa College of Medicine | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Nicholas Mohr, MD nicholas-mohr@uiowa.edu | |
| Principal Investigator: Nicholas M Mohr, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States | |
| Contact: Brian M Fuller, MD 314-747-5368 fullerb@wusm.wustl.edu | |
| Principal Investigator: Brian M Fuller, MD | |
| United States, Ohio | |
| University of Cincinnati College of Medicine | Not yet recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Christopher N Miller, MD millec7@ucmail.uc.edu | |
| Principal Investigator: Christopher N Miller, MD | |
Sponsors and Collaborators
Washington University School of Medicine
University of Iowa
Indiana University School of Medicine
Christiana Care Health System
University of Cincinnati
Investigators
| Principal Investigator: | Brian M Fuller, MD | Washington University School of Medicine in St. Louis |
More Information
No publications provided
| Responsible Party: | Brian Fuller, Assistant Professor of Anesthesiology and Emergency Medicine, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01628523 History of Changes |
| Other Study ID Numbers: | 201205165 |
| Study First Received: | June 20, 2012 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Respiratory failure Mechanical ventilation Acute lung injury |
Additional relevant MeSH terms:
|
Emergencies Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Respiratory Insufficiency Disease Attributes |
Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013