Actively Recruiting
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-07-15
31
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
Sponsors
I
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
A
Azienda Sanitaria dell'Alto Adige
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent form
- Diagnosis of COPD
- Persistent hypercapnia (PaCO2 > 53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring non-invasive ventilation
- Blood pH value above 7.35
- Chronic low oxygen levels (PaO2 < 55 mmHg or < 60 mmHg if polycythemia, pulmonary hypertension, chronic pulmonary heart disease, or >30% of sleep time with oxygen saturation below 90%)
You will not qualify if you...
- Body mass index greater than 30 kg/m2
- Clinically significant obstructive sleep apnea syndrome
- Neuromuscular or chest wall diseases
- Need for intubation and invasive mechanical ventilation during exacerbation
- Current use of home non-invasive mechanical ventilation or CPAP
- Contraindications for non-invasive ventilation
- Cognitive impairment preventing informed consent
- Active and unstable coronary artery syndrome
- Presence of malignancies
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Ospedale S Donato
Arezzo, Italy
Actively Recruiting
2
Bolzano Hospital
Bolzano, Italy
Actively Recruiting
3
Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco"
Catania, Italy
Actively Recruiting
4
ICS Maugeri Spa Società Benefit IRCCS
Pavia, Italy
Actively Recruiting
5
Azienda Unità Sanitaria Locale
Piacenza, Italy
Actively Recruiting
Research Team
L
Lara Pisani, Prof.ssa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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