RecruitingNot ApplicableNCT07065799

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

31 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

COPD Hypercapnia Exacerbation Copd

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different breathing support strategies for people with COPD (a chronic lung disease) who still have too much carbon dioxide in their blood 2–4 weeks after a serious flare-up that required a breathing machine. **You may be eligible if...** - You are 18 or older and have a diagnosis of COPD - You recently had a serious COPD flare-up that required a non-invasive breathing machine (like BiPAP) - Your carbon dioxide levels are still high 2–4 weeks after that episode - You also have chronic low oxygen levels **You may NOT be eligible if...** - Your body mass index (BMI) is over 30 - You have sleep apnea - You have a neuromuscular disease or chest wall problem affecting breathing - You needed a breathing tube during your last flare-up - You already use a home breathing machine or CPAP - You have active cancer or serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGroup 1: NHF/LTOT

Patients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin.

DEVICEGroup 2: HMV/LTOT

Patients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin.