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Sponsored by: |
University of Athens |
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Information provided by: | University of Athens |
ClinicalTrials.gov Identifier: | NCT00416260 |
In the past five years, there is a growing body of published evidence on the feasibility, and oxygenation and lung protection benefits of high frequency oscillation (HFO) in the acute respiratory distress syndrome (ARDS). The investigators have recently demonstrated the short term feasibility and additional benefits with respect to oxygenation of HFO combined with tracheal gas insufflation (TGI). In the present clinical trial, the investigators intend to test the hypothesis that HFO-TGI may result in improved respiratory physiology and clinical course compared to low tidal volume conventional mechanical ventilation in patients with severe ARDS.
Condition | Intervention | Phase |
---|---|---|
Respiratory Distress Syndrome, Adult |
Other: High Frequency Oscillation and Tracheal Gas Insufflation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1/Phase 2, Single-Center, Controlled Study of the Effectiveness of Combined High Frequency Oscillation and Tracheal Gas Insufflation in Improving the Clinical Course of Patients With Severe Acute Respiratory Distress Syndrome |
Enrollment: | 54 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HFO-TGI: Experimental
Patients with severe Acute Respiratory Distress Syndrome receiving sessions of high frequency oscillation and tracheal gas insufflation according to the study protocol
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Other: High Frequency Oscillation and Tracheal Gas Insufflation
Intermittent combined use of High Frequency Oscillation and Tracheal Gas Insufflation until the PaO2/inspired oxygen fraction ratio remains above than 150 mm Hg for more than 24 hours.
|
CMV: No Intervention
Patients with severe Acute Respiratory Distress Syndrome receiving only conventional mechanical ventilation according to the study protocol
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece, Attica | |
Evaggelismos General Hospital | |
Athens, Attica, Greece, GR-106 75 |
Principal Investigator: | Spyros D Mentzelopoulos, Lecturer | First Department of Intensive Care Medicine, University of Athens Medical School |
Principal Investigator: | Sotiris M Malachias, Consultant | First Department of Intensive Care Medicine, University of Athens Medical School |
Study Chair: | Charis Roussos, Professor | First Department of Intensive Care Medicine, University of Athens Medical School |
Study Director: | Spyros G Zakynthinos, As Professor | First Department of Intensive Care Medicine, University of Athens Medical School |
Responsible Party: | University of Athens ( Spyros D Mentzelopoulos, MD, PhD, Lecturer in Intensive Care Medicine ) |
Study ID Numbers: | 10532-HFO-TGI |
Study First Received: | December 26, 2006 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00416260 |
Health Authority: | Greece: Ministry of Health and Welfare |
Respiratory Distress Syndrome, Adult High-Frequency Ventilation Respiration, Artificial |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome |
Pathologic Processes Disease Syndrome |