Respiratory Distress Syndrome, AdultLINKNCT00542737
Evaluating a Web-Based Ventilator Management Educational Program for Clinicians (The Lung Injury Knowledge Network [LINK] Study)
A study testing Web-Based Educational Program in people with Respiratory Distress Syndrome, Adult, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Web-Based Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Sunnybrook Health Sciences
Toronto, Ontario, M4N3M5
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Web-Based Educational Program
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Web-Based Intervention, Lung Preventive Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention Group | Active comparator | Not described Receives: Behavioral: Web-Based Educational Program |
| Delayed Intervention Group | Active comparator | Not described Receives: Behavioral: Web-Based Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients with ALI/ARDS who are receiving LPV
Measured: Measured at Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startFeb 2009
- Primary completionSep 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Gordon D. Rubenfeld, MD, Principal investigator, University of Toronto, Sunnybrook Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542737
- Sponsor's protocol ID
- 518
- Other IDs
- R01HL067939, GC1# A19846
- Acronym
- LINK
- Status last verified
- Aug 2010
- First submitted
- 10 Oct 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Ventilator Management and Preventing Injury to Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00542737
- Acronym / sponsor ID
- LINK / 518
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Web-Based Intervention, Lung Preventive Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Group | Active comparator | Behavioral: Web-Based Educational Program |
| Delayed Intervention Group | Active comparator | Behavioral: Web-Based Educational Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Educational ProgramParticipating 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. | Behavioural | Delayed Intervention Group, Early Intervention Group |
Primary outcome
Percentage of eligible patients with ALI/ARDS who are receiving LPV
Time frame: Measured at Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon D. Rubenfeld, MD principal investigator
University of Toronto, Sunnybrook Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Educational Program in people with Respiratory Distress Syndrome, Adult, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible patients with ALI/ARDS who are receiving LPV (time frame: Measured at Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.