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Study of a Novel Technique of Mechanical Ventilation in Patients With Severe Acute Respiratory Failure

NCT00637507 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-11-21

No results posted yet for this study

Summary

The investigators have recently demonstrated the beneficial effects of combined high-frequency oscillation (HFO) and tracheal gas insufflation (TGI) on the respiratory physiology \[1,2\] of patients with severe acute respiratory distress syndrome (ARDS) (NCT00416260). Preliminary short-term survival results were also encouraging. Consequently, in the present clinical trial, the investigators intend to increase the size of the studied population, in order to evaluate the effect of HFO-TGI on survival with adequate statistical power. Furthermore, the investigators intend to elucidate the mechanism of the HFO-TGI-related physiological benefit.

Conditions

  • Respiratory Distress Syndrome

Interventions

OTHER

High-frequency Oscillation and Tracheal Gas Insufflation

Patients will receive daily sessions of High-frequency Oscillation and Tracheal Gas Insufflation (HFO-TGI), which will last at least 6 hours. These sessions will comprise a recruitment period of at least 90 min, a stabilization period of at least 4 hours, and a weaning period of at least 60 min. The HFO-TGI strategy will be aimed at initially maximizing PaO2/FiO2 without causing hemodynamic compromise (e.g., \>10% reduction in cardiac output/index), and subsequently maintaining PaO2/FiO2 \>150 mm Hg, while gradually reducing mPaw to 4-6 cm H2O below its initial setting. The weaning from TGI and HFO will be according to the reversal of the oxygenation criterion that mandated their use (see also Detailed Description).

Sponsors & Collaborators

  • University of Thessaly

    collaborator OTHER

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, MD, PhD · University of Athens Medical School, Athens, Greece

  • Sotiris Malachias, MD · Department of Intensive Care Medicine, Evaggelismos Hospital, Athens, Greece

  • Spyros G Zakynthinos, MD, PhD · University of Athens Medical School, Athens, Greece

  • Charis Roussos, MD, PhD · University of Athens Medical School, Athens, Greece

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
2008-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

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 NCT00637507 on ClinicalTrials.gov