Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
Key facts
- Where
- Arezzo, Bolzano, Catania, Pavia, and Piacenza, ItalySee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07065799, who can take part
Where in Italy
- Ospedale S DonatoArezzo, ItalyTaking people
- Bolzano HospitalBolzano, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco"Catania, ItalyTaking people
- ICS Maugeri Spa Società Benefit IRCCSPavia, ItalyTaking people
- Azienda Unità Sanitaria LocalePiacenza, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Trial code
- NCT07065799
- Record updated
- 15 July 2025
- Original description
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.Read full original descriptionShow less
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study
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
Inclusion: 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; pH value >7.35; Chronic hypoxemia (PaO2 <55mmHg or <60mmHg if at least one of the following criteria is present: polycythemia, pulmonary hypertension or Chronic Pulmonary Heart Disease, >30% of sleep time with SpO2 < 90% measured with a pulse oximeter).
Exclusion: 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; Presence of cognitive impairment that would prevent informed consent into the trial; Patients with active and unstable coronary artery syndrome; Patients suffering from malignancies; BMI >30 kg/m2; Need for intubation and invasive mechanical ventilation during exacerbation; Use of home non-invasive mechanical ventilation or CPAP; Contraindications for NIV.