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Combined High Frequency Oscillation and Tracheal Gas Insufflation for Severe Acute Respiratory Distress Syndrome

NCT00416260 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-06-24

No results posted yet for this study

Summary

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.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

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.

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, Lecturer · First Department of Intensive Care Medicine, University of Athens Medical School

  • Sotiris M Malachias, Consultant · First Department of Intensive Care Medicine, University of Athens Medical School

  • Charis Roussos, Professor · First Department of Intensive Care Medicine, University of Athens Medical School

  • Spyros G Zakynthinos, As Professor · First Department of Intensive Care Medicine, University of Athens Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416260 on ClinicalTrials.gov