Clinical trial NCT00182195: Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
Official title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation
* Acute respiratory insufficiency (within past 28 days)
* Bilateral infiltrates on frontal chest radiograph
* Hypoxemia, defined as PaO2/FiO2\<=250

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Hospital Mortality
Secondary outcomes:
measure: Mortality attributed to respiratory failure
measure: Duration of respiratory failure and duration of mechanical failure
measure: Evaluation of respiratory function during mechanical ventilation
measure: Incidence of barotraumas
measure: Non-respiratory organ dysfunction
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen O Meade, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Meade 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.