Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome

NCT00182195 | Completed Phase 3 DMC

• 1 other identifier: 38141-1
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Control Ventilation Strategy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, L8L 5G4, Canada

Location

Related Publications (2)

• 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.

  PMID: 25593749 DERIVED

• 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.

  PMID: 18270352 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Maureen O Meade, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2000
• Study Completion: March 1, 2006
• Last Updated: April 23, 2007

Record last verified: 2007-04

Locations

CA (1)