Stopped: due to the "Philips alert " we could not get the treatment equipment and the public grands expired
0Started 2023-01
Plain-language summary
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. º.- Patient between 18 and 85 years old.
✓. º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
✓. º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
✓. º.- No NIV or CPAP home therapy in the last 6 months\[\*\].
✓. º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
✓. º.- Providing informed consent (dated and signed).
Exclusion criteria
✕. º.- With moderate or severe chronic obstructive pulmonary disease (FEV1\<70% of predicted when FEV1/FVC is below 70%).
✕. º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
✕. º.- Inability to maintain a patent airway or adequately clear secretions.
✕. º.- With bullous lung disease or with pneumothorax.
✕. º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
✕. º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus.
✕. º.- At risk for aspiration of gastric contents.
✕. º.- Diagnosed with acute sinusitis or otitis media.