Status:
TERMINATED
High Frequency Oscillatory Ventilation for Acute Respiratory Distress Syndrome (ARDS)
Lead Sponsor:
University of Athens
Collaborating Sponsors:
University of Thessaly
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 Maneu...
Detailed Description
BACKGROUND AND RATIONALE Recent two-center results (1) support a beneficial effect of combined high-frequency oscillation (HFO), recruitment maneuvers (RMs) and tracheal gas insufflation (TGI) on the ...
Eligibility Criteria
Inclusion
- early ARDS (establishment of the diagnosis within the preceding 72 hours) according to the criteria of the American-European Consensus Conference (5),
- Moderate-to-severe oxygenation disturbance \[defined as ratio of partial pressure of arterial oxygen (PaO2) to inspired oxygen fraction (FiO2)\<200 mmHg, while being ventilated with positive end-expiratory pressure (PEEP) set at ≥10 cmH2O for at least 12 hours,
- age 18-75 years, body weight \>40 Kg,
Exclusion
- severe air leak (more than one chest tubes per hemithorax with persistent air leak for more than 72 hours),
- systolic blood pressure lower than 90 mmHg and/or mean blood pressure lower than 65 mmHg, despite maximum support with fluids and vasopressor drugs (i.e., norepinephrine infusion rate exceeding 0.5 μg/kg/min,
- significant heart disease (e.g. ejection fraction lower than 40%, history of pulmonary edema and active ischemic disease or myocardial infarction),
- severe chronic obstructive pulmonary disease (COPD) or asthma (e.g. previous admission for COPD/asthma, chronic treatment with corticosteroids for COPD/asthma, and chronic CO2 retention more than 50 mmHg),
- intracranial pathology with intracranial pressure \>20 mmHg, not responsive to maximum conservative treatment (e.g. hemorrhage, head injury, tumor, infection or acute ischemic stroke),
- chronic interstitial lung disease with bilateral lung infiltrates,
- lung biopsy or incision during the current admission,
- previous lung transplantation or bone marrow transplantation, i) pregnancy,
- immunosuppression, and
- participation in another clinical study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01478802
Start Date
November 1 2011
End Date
November 1 2013
Last Update
April 28 2015
Active Locations (2)
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1
Evaggelismos General Hospital
Athens, Attica, Greece, GR-10675
2
Larisa University General Hospital
Larissa, Thessaly, Greece, GR-41110