NCT00542737

Brief Summary

Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Individuals with ALI/ARDS often require the use of a respirator or artificial breathing machine, known as a mechanical ventilator, while in an intensive care unit (ICU). Research has shown that lung protective ventilation (LPV), a type of mechanical ventilation technique, is an effective way to reduce the number of deaths due to ALI/ARDS. This study will evaluate the effectiveness of a Web-based educational program that aims to educate ICU clinicians about the use of LPV in patients with ALI/ARDS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 11, 2013

Status Verified

August 1, 2010

Enrollment Period

4.6 years

First QC Date

October 10, 2007

Last Update Submit

July 9, 2013

Conditions

Keywords

Acute Lung InjuryAcute Respiratory Distress SyndromeAcute Respiratory FailureWeb-Based InterventionLung Preventive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Percentage of eligible patients with ALI/ARDS who are receiving LPV

    Measured at Month 6

Study Arms (2)

Early Intervention Group

ACTIVE COMPARATOR
Behavioral: Web-Based Educational Program

Delayed Intervention Group

ACTIVE COMPARATOR
Behavioral: Web-Based Educational Program

Interventions

Participating clinicians at each hospital will access the Web site as often as necessary for a 6-month period. The Web site will contain background and educational information on ALI/ARDS and LPV, including how to recognize ALI/ARDS and how to implement LPV in patients. Scholarly articles and other materials, including a chart to help clinicians determine appropriate ventilator settings for each patient, will be available to download. Clinicians will also be able to email questions to critical care experts.

Delayed Intervention GroupEarly Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 10 and 20 ICU beds with 5 to 10 ALI/ARDS patients cared for each month
  • Provide critical care services
  • Keep electronic medical records on ICU patients
  • ICU staff must have access to computers with Intranet or Internet
  • Provide care for mechanically ventilated patients in ICUs
  • Willing to participate by viewing Web site

You may not qualify if:

  • Cardiac, cardiothoracic, neurosurgical, neonatal, or pediatric ICUs
  • Residents and fellows must provide care to majority of critically ill patients
  • Fewer than 5 to 10 ALI/ARDS patients cared for each month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto, Sunnybrook Health Sciences

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Gordon D. Rubenfeld, MD

    University of Toronto, Sunnybrook Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

February 1, 2009

Primary Completion

September 1, 2013

Study Completion

July 1, 2014

Last Updated

July 11, 2013

Record last verified: 2010-08

Locations