Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07065799

Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-07-15

31

Participants Needed

5

Research Sites

4 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

Researchers are evaluating respiratory strategies in patients with COPD and persistent high carbon dioxide levels following a severe flare-up. This study compares two treatments: high flow nasal cannula (NHF) combined with standard oxygen therapy, and home mechanical ventilation (HMV) combined with standard oxygen therapy. The goal is to determine if NHF provides similar benefits to HMV in reducing carbon dioxide levels in the blood. Participants will be randomly assigned to start with either NHF plus oxygen therapy or HMV plus oxygen therapy. Each treatment lasts three months, separated by a one-week washout period to avoid carry-over effects. The total treatment duration, including the washout, is around 25 weeks. NHF involves using a device delivering heated, humidified air through nasal cannula for at least six hours nightly, while HMV uses a ventilator with a mask for at least six hours nightly plus oxygen therapy for at least 15 hours daily. During the study, participants will undergo assessments at baseline, after three months, and after six months, including blood gas tests to measure carbon dioxide and oxygen levels, lung function tests, exercise capacity tests, symptom and quality of life questionnaires, and sleep quality evaluations. Compliance and tolerance to each respiratory support will be monitored by device usage data and patient feedback. Researchers will also track exacerbations, hospitalizations, and survival over 12 months to evaluate the treatments' effects.

CONDITIONS

Brief Title

Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed informed consent form
  • Diagnosed with COPD
  • Persistent hypercapnia (PaCO2 >53 mmHg) 2-4 weeks after an acute hypercapnic COPD exacerbation requiring non-invasive ventilation
  • pH value greater than 7.35
  • Chronic low oxygen levels (PaO2 <55 mmHg or <60 mmHg with polycythemia, pulmonary hypertension, chronic pulmonary heart disease, or >30% sleep time with SpO2 <90%)
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 months

Participants start treatment with one of two respiratory strategies: nasal high flow (NHF) plus oxygen therapy or home mechanical ventilation (HMV) plus oxygen therapy, each for 3 months at home.

Visits at baseline and at 3 months for assessments

Washout Period

Duration - 7 days

Participants undergo a 7-day washout period without either respiratory support to minimize carry-over effects between treatments.

No visits required

Implementation

Duration - 3 months

Participants switch to the alternate respiratory strategy (NHF or HMV) plus oxygen therapy for another 3 months at home.

Visits at treatment start and completion for assessments

Follow-up

Duration - Up to 12 months

Participants are monitored for exacerbations, hospitalizations, and survival for up to 12 months since the beginning of treatment.

Periodic follow-up visits for outcome assessments

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

Loading map...

Research Team

L

Lara Pisani, Prof.ssa

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Multicenter, Prospective Trial Evaluating the Safety and E...

Emphysema or COPD

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial.

Patrick B Murphy, Sunita Rehal, Gill Arbane...

https://pubmed.ncbi.nlm.nih.gov/28528348

Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure.

Line Hust Storgaard, Hans-Ulrich Hockey, Birgitte Schantz Laursen...

https://pubmed.ncbi.nlm.nih.gov/29713153

The Danish respiratory society guideline for long-term high flow nasal cannula treatment, with or without supplementary oxygen.

Ulla Møller Weinreich, Kasper Svendsen Juhl, Malene Søby Christophersen...

https://pubmed.ncbi.nlm.nih.gov/36861118