Respiratory Distress Syndrome Clinical Trial
— HFO-TGI-2Official title:
Phase II/Phase III Study of the Effect of Combined High-frequency Oscillation and Tracheal Gas Insufflation on the Survival to Hospital Discharge of Patients With Severe Acute Respiratory Distress Syndrome
Verified date | November 2016 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Department of Intensive Care Medicine, Evaggelismos Hospital | Athens | Attica |
Greece | University General Hospital of Larissa | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Athens | University of Thessaly |
Greece,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival to days 28 and 60 post-randomization, and to Hospital Discharge | 28 days to more than 60 days post-randomization | No | |
Secondary | Lung recruitment during the study-intervention period | 8 days post-randomization | No | |
Secondary | Evolution of Gas-exchange, Hemodynamics, and Respiratory Mechanics during the Study Intervention Period | 8-10 days post-randomization | No | |
Secondary | Ventilator Free Days | 60 days post-randomization | No | |
Secondary | Organ or System Failure Free Days | 60 days post-randomization | No | |
Secondary | Occurrence of barotrauma (i.e., any new pneumothorax, pneumomediastinum, or subcutaneous emphysema, or pneumatocele > 2 cm) | 60 days post-randomization | Yes | |
Secondary | Occurence of Tracheal Mucosal Injury due to use of Tracheal Gas Insufflation | 8-10 days post-randomization | Yes |
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