31
Participants
Start Date
June 30, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
January 31, 2028
Group 1: NHF/LTOT
Patients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin.
Group 2: HMV/LTOT
Patients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin.
RECRUITING
Ospedale S Donato, Arezzo
RECRUITING
Bolzano Hospital, Bolzano
RECRUITING
"Azienda Ospedaliera Universitaria Policlinico G. Rodolico-Sn Marco", Catania
RECRUITING
ICS Maugeri Spa Società Benefit IRCCS, Pavia
RECRUITING
Azienda Unità Sanitaria Locale, Piacenza
Azienda Sanitaria dell'Alto Adige
OTHER
Ospedale San Donato
OTHER
Azienda Unita Sanitaria Locale di Piacenza
OTHER
Policlinico Universitario, Catania
OTHER
Fondazione Salvatore Maugeri
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER