Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

NARecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

January 31, 2028

Conditions
COPDHypercapniaExacerbation Copd
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (5)

Unknown

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

All Listed Sponsors
collaborator

Azienda Sanitaria dell'Alto Adige

OTHER

collaborator

Ospedale San Donato

OTHER

collaborator

Azienda Unita Sanitaria Locale di Piacenza

OTHER

collaborator

Policlinico Universitario, Catania

OTHER

collaborator

Fondazione Salvatore Maugeri

OTHER

lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER