Comparing High Flow Nasal Cannula and Home Mechanical Ventilation for COPD Patients with Persistent High Carbon Dioxide After Severe Exacerbation A 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
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
Research Team
L
Lara Pisani, Prof.ssa
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
Azienda Sanitaria dell'Alto Adige
Collaborating Sponsor
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
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%)
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
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
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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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.