Status:
COMPLETED
Study of a Novel Technique of Mechanical Ventilation in Patients With Severe Acute Respiratory Failure
Lead Sponsor:
University of Athens
Collaborating Sponsors:
University of Thessaly
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 w...
Detailed Description
BACKGROUND AND OBJECTIVES The prognosis of ARDS still remains grave \[3-7\]. The primary objective of the present study, is to definitively determine the effect of HFO-TGI on the survival of patients...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Body weight \> 40 kg
- Endotracheal intubation and mechanical ventilation
- Diagnosis of ARDS established within preceding 72 h
- Severe oxygenation disturbances: PaO2/FiO2 \<150 mm Hg sustained for 12 h, despite being ventilated with PEEP ≥8 cm H2O
Exclusion
- Active air leak or recent severe air leak (severe air leak: \> 1 chest tube per hemithorax with persistent gas leak for \> 72 h)
- Severe hemodynamic instability (i.e., systolic arterial pressure \< 90 mm Hg despite volume loading and norepinephrine infusion at ≥ 0.5 μg/kg/min)
- Significant heart disease (i.e., ejection fraction \<40 %, and/or history of pulmonary edema, and/or active coronary ischemia or myocardial infarction)
- Significant chronic obstructive pulmonary disease (COPD) or asthma {i.e., previous admissions for COPD/asthma, chronic corticosteroid therapy for COPD/asthma, and documented chronic CO2 retention leading to a baseline PaCO2 of \> 50 mm Hg (for COPD)}
- Uncontrollable intracranial hypertension (i.e., intracranial pressure \>20 mm Hg despite deep sedation, analgesia, hyperosmolar therapy, and minute ventilation titrated to PaCO2 = 35 mm Hg)
- Chronic Interstitial Lung Disease associated with bilateral pulmonary infiltrates
- Lung biopsy or resection on current admission
- Immunosuppression caused by
- neutropenia \[i.e., polymorphonuclear leukocyte count \< 1,000/μL (1 x 1012/L)\] after chemotherapy or bone marrow transplantation for hematologic cancers
- corticosteroid or cytotoxic therapy for a nonmalignant disease
- the acquired immunodeficiency syndrome
- Inability to wean from prone positioning or inhaled nitric oxide
- Pregnancy or morbid obesity (body mass index \>40 kg/m2)
- Enrollment in another interventional study
- Crossover from the CMV-group to the HFO-TGI-group at \> 72 h after the onset of the severe oxygenation disturbances
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00637507
Start Date
March 1 2008
End Date
May 1 2009
Last Update
November 21 2016
Active Locations (2)
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1
Department of Intensive Care Medicine, Evaggelismos Hospital
Athens, Attica, Greece, GR-10675
2
University General Hospital of Larissa
Larissa, Thessaly, Greece, GR-41110