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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00431158 |
Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator.
The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.
Condition | Intervention |
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Respiratory Distress Syndrome, Adult |
Other: Different Mechanical Ventilation Protocols |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial |
Estimated Enrollment: | 600 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
ARDSnet Protocol
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Other: Different Mechanical Ventilation Protocols
OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol |
2: Active Comparator
OLA Protocol
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Other: Different Mechanical Ventilation Protocols
OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol |
The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures.
Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert M Kacmarek, Ph.D., RRT | 617-724-4480 | rkacmarek@partners.org |
Contact: Demet S Suleymanci, MD | 617-724-4498 | dsuleymanci@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: R. Scott Harris, MD |
Principal Investigator: | Robert M Kacmarek, Ph.D., R.R.T | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Robert Kacmarek, PhD, RRT ) |
Study ID Numbers: | 2006-P-001878, BWH IRB Assurance #FWA00000484 |
Study First Received: | February 1, 2007 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00431158 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Respiratory Distress Syndrome ARDS Respiratory failure |
Mechanical Ventilation Positive end expiratory pressure Lung recruitment maneuver |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
Pathologic Processes Disease Respiratory Tract Diseases Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult |