ARDSNET STUDY PDF

The first clinical trial completed by the Network was a randomized, controlled trial of Ketoconazole versus placebo in patients with acute lung injury and ARDS. It enrolled participants. The LARMA study was a randomized, double-blind, placebo-controlled multi-center study with where each patient was randomized between Lisofylline and Placebo. It was designed to test whether the administration of lisofylline early after the onset of ALI or ARDS would reduce mortality and morbidity.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. 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.

OLA Group: Open lung approach protocol and recruitment maneuvers. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study. Warning You have reached the maximum number of saved studies ARDSnet Protocol vs.

Open Lung Approach in ARDS The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Last Update Posted : September 18, Study Description. 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.

Detailed Description:. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. T Massachusetts General Hospital. More Information. Publications automatically indexed to this study by ClinicalTrials. Crit Care Med.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Respiratory Distress Syndrome, Adult.

Other: Different Mechanical Ventilation Protocols. Not Applicable. Study Type :. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Robert M. Mechanical Ventilation Positive end expiratory pressure Lung recruitment maneuver.

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Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. 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.

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ARDSnet Ventilation Strategy

ARDS is mediated by alveolar damage from the release of inflammatory mediators. However, multiple animal studies and observational studies showed that these large tidal volumes and the consequential elevated plateau pressures were associated with significant barotrauma. The mean tidal volumes on days 1 to 3 were 6. This trial was investigated by the Office of Human Research Protections OHRP for ethical concerns, specifically that the educational materials as part of the informed consent process were inadequate. Despite the trial's controversies, the benefit of low Vt ventilation has been supported by a recent Cochrane meta-analysis.

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Mechanical ventilation: lessons from the ARDSNet trial

Study record managers: refer to the Data Element Definitions if submitting registration or results information. Despite 20 years of research into the mechanisms that cause this syndrome and numerous developments in the technology of mechanical ventilation, the mortality has remained greater than 50 percent. Many of the patients are young, and to the tragic loss of human life can be added the cost to society because these patients spend an average of 2 weeks in intensive care units and require multiple high tech procedures. Because of the overwhelming nature of the lung injury once it is established, prevention would appear to be the most effective strategy for improving the outlook in this condition.

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