- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542737
Evaluating a Web-Based Ventilator Management Educational Program for Clinicians (The Lung Injury Knowledge Network [LINK] Study) (LINK)
Improving Ventilator Management and Preventing Injury to Patients With Acute Respiratory Failure
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- University of Toronto, Sunnybrook Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Gordon D. Rubenfeld, MD, University of Toronto, Sunnybrook Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 518
- R01HL067939 (U.S. NIH Grant/Contract)
- GC1# A19846
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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