ED Lung Protective Ventilation to Reduce Complications

NCT02543554 | Completed Results

• 1 other identifier: 201409024
• Study Type: observational
• Target: 1,705
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation; Ventilator-associated Conditions; ARDS

Outcome Measures

Primary Outcomes (1)

• Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department

  7 days

Secondary Outcomes (1)

• Number of Patients That Die During the Hospitalization

  Patients will be followed for the duration of hospital stay

Study Arms (2)

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

Interventions

lung protective ventilation PROCEDURE

Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.

Intervention group

Eligibility Criteria

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

Study Population

mechanically ventilated patients in the emergency department

You may qualify if:

• mechanically ventilated via an endotracheal tube in the ED

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washinton University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Roberts BW, Mohr NM, Ablordeppey E, Drewry AM, Ferguson IT, Trzeciak S, Kollef MH, Fuller BM. Association Between Partial Pressure of Arterial Carbon Dioxide and Survival to Hospital Discharge Among Patients Diagnosed With Sepsis in the Emergency Department. Crit Care Med. 2018 Mar;46(3):e213-e220. doi: 10.1097/CCM.0000000000002918.

  PMID: 29261567 DERIVED

• Fuller BM, Ferguson I, Mohr NM, Stephens RJ, Briscoe CC, Kolomiets AA, Hotchkiss RS, Kollef MH. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications. BMJ Open. 2016 Apr 11;6(4):e010991. doi: 10.1136/bmjopen-2015-010991.

  PMID: 27067896 DERIVED

Results Point of Contact

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

fullerb@wustl.edu

3147475368

Study Officials

• Brian M Fuller, MD, MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Emergency Medicine

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 3, 2018
• Results First Posted: December 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)