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Evaluating a Web-Based Ventilator Management Educational Program for Clinicians (The Lung Injury Knowledge Network [LINK] Study)
This study is not yet open for participant recruitment.
Verified by National Heart, Lung, and Blood Institute (NHLBI), November 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00542737
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome, Adult
Behavioral: Web-Based Educational Program

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Improving Ventilator Management and Preventing Injury to Patients With Acute Respiratory Failure

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Percentage of eligible patients with ALI/ARDS who are receiving LPV [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early Intervention Group: Active Comparator Behavioral: Web-Based Educational Program
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 Group: Active Comparator Behavioral: Web-Based Educational Program
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542737

Contacts
Contact: Venika Manoharan, HBSc 416-480-6100 ext 88136 venika.manoharan@sunnybrook.ca

Locations
Canada, Ontario
University of Toronto, Sunnybrook Health Sciences
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Investigators
Principal Investigator: Gordon D. Rubenfeld, MD University of Toronto, Sunnybrook Health Sciences
  More Information

Responsible Party: University of Toronto, Sunnybrook Health Sciences ( Gordon D. Rubenfeld, MD )
Study ID Numbers: 518, R01 HL067939, GC1# A19846
Study First Received: October 10, 2007
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00542737  
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Acute Lung Injury
Acute Respiratory Distress Syndrome
Acute Respiratory Failure
Web-Based Intervention
Lung Preventive Ventilation

Study placed in the following topic categories:
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009