Evaluating a Web-Based Ventilator Management Educational Program for Clinicians (The Lung Injury Knowledge Network [LINK] Study) (LINK)

July 9, 2013 updated by: Sunnybrook Health Sciences Centre

Improving Ventilator Management and Preventing Injury to Patients With Acute Respiratory Failure

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.

Study Overview

Detailed Description

ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. Common causes include pneumonia, septic shock, and lung trauma, and most patients require immediate care in an ICU. The main form of treatment for ALI/ARDS is the delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation. Each year, 74,500 people die due to ALI/ARDS and 22% of these deaths could be prevented with the use of LPV. LPV is a mechanical ventilation technique in which lower volumes of oxygen are administered. The purpose of this study is to implement and evaluate a Web-based educational program that will provide educational and instructional resources about ALI/ARDS and LPV to ICU clinicians, including physicians, nurses, and respiratory therapists.

Hospitals participating in this study will be randomly assigned to access the Web site at either the beginning of the study period or a later time. 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. At the end of the 6-month study period, study staff will compare the number of patients receiving LPV to the number of patients who received LPV prior to the start of the study.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • University of Toronto, Sunnybrook Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Hospitals:

  • 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

Inclusion Criteria for Clinicians:

  • Provide care for mechanically ventilated patients in ICUs
  • Willing to participate by viewing Web site

Exclusion Criteria for Hospitals:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Intervention Group
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.
Active Comparator: Delayed Intervention Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of eligible patients with ALI/ARDS who are receiving LPV
Time Frame: Measured at Month 6
Measured at Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gordon D. Rubenfeld, MD, University of Toronto, Sunnybrook Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimate)

October 11, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

August 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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