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

Inclusion Criteria6

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)

Exclusion Criteria9

BMI \>30 kg/m2
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
Need for intubation and invasive mechanical ventilation during exacerbation
Use of home non-invasive mechanical ventilation or CPAP
Contraindications for NIV
Presence of cognitive impairment that would prevent informed consent into the trial
Patients with active and unstable coronary artery syndrome
Patients suffering from malignancies

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.