Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation.
The purpose is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Partecipants will be randomized at 1:1 ratio into two groups:
group 1: will start the respiratory strategy under study (NHF + standard oxygen therapy) as first treatment group 2 will start the control respiratory strategy (HMV + standard oxygen therapy) as first treatment.
The study has a crossover design: each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months
Eligibility criteria
Qualifiers
Age ≥18 years
Acquisition of informed consent form
Patients with COPD
Persistent hypercapnia (PaCO2 >53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring NIV.
Disqualifiers
BMI >30 kg/m2
Clinically significant obstructive sleep apnea syndrome (patients in whom there was a clinical suspicion of OSA syndrome based on clinical review or overnight oximetry will go further testing with limited respiratory polygraphy)
Neuromuscular or chest wall diseases
Need for intubation and invasive mechanical ventilation during exacerbation
Trial design
Treatments tested in this trial
- Group 1: NHF/LTOT
- Group 2: HMV/LTOT
Treatment groups
31 Participants
are divided into 2 treatment groupsSponsors and collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
Azienda Sanitaria dell'Alto Adige
Collaborator
Ospedale San Donato
Collaborator
Azienda Unita Sanitaria Locale di Piacenza
Collaborator
Policlinico Universitario, Catania
Collaborator
Fondazione Salvatore Maugeri
Collaborator
Source ClinicalTrials.gov