NCT07065799Recruiting
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study
Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 17 May 2024
- Start date
- 30 Jun 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- COPD
- NCT number
- NCT07065799
What you commit to
- Study type: Interventional
- Planned participants: 31
- From 30 Jun 2024 to the primary completion date, 31 Dec 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale S Donato Coordinator of this site? Confirm its status | Arezzo | Italy | Recruiting |
| Bolzano Hospital Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco" Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| ICS Maugeri Spa Società Benefit IRCCS Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Unità Sanitaria Locale Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.