Acute Respiratory Distress SyndromePhase 3LOVSNCT00182195
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
A Phase 3 study of Acute Respiratory Distress Syndrome, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- Type of treatment
- Surgery or procedure
- How many people
- 980 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2000to Mar 2006
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation
- Acute respiratory insufficiency (within past 28 days)
- Bilateral infiltrates on frontal chest radiograph
- Hypoxemia, defined as PaO2/FiO2<=250
Who cannot join
- Primary cause of respiratory failure is cardiac
- Anticipated duration of mechanical ventilation < 48 hours
- Inability to wean other experimental ventilation strategies
- Severe chronic respiratory disease
- Neuromuscular disease that will prolong mechanical ventilation
- Conditions where hypercapnia-induced intracranial hypertension should be avoided
Show all 12Show fewer
- Morbid obesity (> 1Kg per cm body weight)
- Pregnancy
- Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality >= 50%
- Greater than 48 hours elapsed since first eligible
- Current participation in competing trial
- Lack of physician, patient or proxy consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, L8L 5G4
About this study
Official title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.
Read the detailed description
To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Control Ventilation Strategy
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Ventilation StrategyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
Secondary outcomes (5)
Mortality attributed to respiratory failure
Duration of respiratory failure and duration of mechanical failure
Evaluation of respiratory function during mechanical ventilation
Incidence of barotraumas
Non-respiratory organ dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2000
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 980 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Maureen O Meade, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182195
- Sponsor's protocol ID
- 38141-1
- Acronym
- LOVS
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 23 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mehta S, Cook DJ, Skrobik Y, Muscedere J, Martin CM, Stewart TE, Burry LD, Zhou Q, Meade M. A ventilator strategy combining low tidal volume ventilation, recruitment maneuvers, and high positive end-expiratory pressure does not increase sedative, opioid, or neuromuscular blocker use in adults with acute respiratory distress syndrome and may improve patient comfort. Ann Intensive Care. 2014 Nov 6;4:33. doi: 10.1186/s13613-014-0033-9. eCollection 2014.
PubMed 25593749Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.
PubMed 18270352
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT00182195
- Acronym / sponsor ID
- LOVS / 38141-1
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2000
- Study completion
- Mar 2006 (actual)
- First posted
- 16 Sep 2005 (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.
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.
Detailed description
To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Invasive mechanical ventilation
- Acute respiratory insufficiency (within past 28 days)
- Bilateral infiltrates on frontal chest radiograph
- Hypoxemia, defined as PaO2/FiO2<=250
Key exclusion criteria (12 listed)
- Primary cause of respiratory failure is cardiac
- Anticipated duration of mechanical ventilation < 48 hours
- Inability to wean other experimental ventilation strategies
- Severe chronic respiratory disease
- Neuromuscular disease that will prolong mechanical ventilation
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 |
|---|---|---|
| Control Ventilation Strategy | Procedure or surgery | – |
Primary outcome
Hospital Mortality
5 secondary outcomes
Mortality attributed to respiratory failure
Duration of respiratory failure and duration of mechanical failure
Evaluation of respiratory function during mechanical ventilation
Incidence of barotraumas
Non-respiratory organ dysfunction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2007.
- Derived from this study: PubMed 25593749Mehta S, Cook DJ, Skrobik Y, Muscedere J, Martin CM, Stewart TE, Burry LD, Zhou Q, Meade M. A ventilator strategy combining low tidal volume ventilation, recruitment maneuvers, and high positive end-expiratory pressure does not increase sedative, opioid, or neuromuscular blocker use in adults with acute respiratory distress syndrome and may improve patient comfort. Ann Intensive Care. 2014 Nov 6;4:33. doi: 10.1186/s13613-014-0033-9. eCollection 2014.
- Derived from this study: PubMed 18270352Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.
Related trials for Acute Respiratory Distress Syndrome
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
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.
Maureen O Meade, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Acute Respiratory Distress Syndrome, run by Hamilton Health Sciences Corporation 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 23 Apr 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital Mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182195, which also lists 2 linked publications.
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 23 Apr 2007.