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High Frequency Oscillatory Ventilation for Acute Respiratory Distress Syndrome (ARDS)

NCT01478802 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-04-28

No results posted yet for this study

Summary

Based on recent two-center results (Eur Respir J. 2011 Sep 1. \[Epub ahead of print\] PMID: 21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96 hours (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises to \>200 mmHg for \>12 hours), followed by return to lung protective conventional mechanical ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10 postrandomization, patients will be returned to HFO upon recurrence of their moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive lung protective CMV.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DEVICE

Lung protective CMV

Low tidal volume-high positive end-expiratory pressure conventional mechanical ventilation (CMV) and recruitment maneuvers, as specified in detail in the Detailed Description Section.

DEVICE

HFO-RMs

Initial, 96-hour-lasting session (session duration modifiable according to oxygenation criteria) of High-frequency oscillation (HFO) combined with recruitment Maneuvers (RMs), followed by additional HFO-RMs sessions (if required according to the study protocol oxygenation criteria)during days 1-10. During the rest of the intervention period, patients will be treated with the same lung protective CMV strategy of the CMV arm. Additional details are provided in the Detailed Description Section.

Sponsors & Collaborators

  • University of Thessaly

    collaborator OTHER

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, A. Professor · Evaggelismos Hospital, Dept. of Intensive Care Medicine, University of Athens Medical School

  • Spyros G Zakynthinos, Professor · Evaggelismos Hospital, Dept. of Intensive Care Medicine, University of Athens Medical School

  • Paschalis Sideras, PHD · Institute of Biomedical Research of the Athens Academy of Sciences

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
2011-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01478802 on ClinicalTrials.gov