Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
Christiana Care Health Services
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: March 28, 2014
Last verified: March 2014
  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 ]

Enrollment: 259
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628523

Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Iowa
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Sponsors and Collaborators
Washington University School of Medicine
University of Iowa
Christiana Care Health Services
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: March 28, 2014
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:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014