An interventional study of Group 1: NHF/LTOT and Group 2: HMV/LTOT in COPD, Hypercapnia and Exacerbation Copd, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 5 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment
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
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 of this study 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.
Patients will be randomly assigned through a simple randomization list, stratified by recruiting center, generated by the Stata statistical software. Based on this list, patients will be divided into two groups: group 1 will start as the first treatment with the respiratory strategy under study (NHF + standard oxygen therapy) and group 2 will start as the first treatment with the control respiratory strategy (HMV + standard oxygen therapy). Randomization will occur at a 1:1 ratio. 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. To minimize the carry-over effect, a washout period of 7 days between respiratory supports will be scheduled. Therefore, considering the washout period, the total treatment duration is 25 weeks.
Exclusion Criteria:
NHF/LTOT
Device: Group 1: NHF/LTOT
HMV/LTOT
Device: Group 2: HMV/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.
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.
Evaluation of the non-inferiority of the change in PaCO2 levels measured during treatment with NHF respiratory support compared to HMV respiratory support, both associated with standard oxygen therapy.
Unity of measurement: mmHg
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of the time required for setting up and adjusting the two respiratory strategies.
Unit of measurement: days
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of PaO2 levels measured via arterial blood gas analysis
Unit of measurement: mmHg
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
FVC, FEV1
Measured by spirometry Unit of measurement for FVC and FEV1: L
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)
Unit of measurement: meters
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of dyspnea measured using the Medical Research Council Dyspnea score
mMRC score ranges from 0 to 4. 0=No dyspnea symptoms 4=severe dyspnea
Time frame: aT0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of life measured using the St. George's Respiratory Questionnaire
SGRQ's Total Score ranges between 0 and 100, where 0 is maximum quality of life and 100 is lowest quality of life
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index
PSQI ranges from 0 to 21, higher score indicate worse sleep quality
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support.
Time of usage of the respiratory support in hours/day and hours/night.
Time frame: T1 (+3months), T2 (+6months)
Evaluation of tolerance to respiratory supports meauserd using visual analog scales
Visual analog scale ranges between 0 to 10, 0=minimum tolerance 10=maximum tolerance
Time frame: T1 (+3months), T2 (+6months)
Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred.
Unit of measurement: number of events
Time frame: three, six and 12 month since the beginning of the treatment
Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations
Unity of measurement: number of exacerbation that required hospitalisation
Time frame: T1 (+3months), T2 (+6months) and T3 (+12months)
Evaluation of survival measured by mortality analysis
Time frame: T1 (+3months), T2 (+6months) and T3 (+12 months)
Plan to share: No
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IRCCS Azienda Ospedaliero-Universitaria di Bologna