COPD, Exacerbation Copd, Hypercapnia
Conditions
Keywords
COPD, hypercapnia, NHF, HMV, PaCO2
Brief 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
Detailed description
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.
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.
Sponsors
Azienda Sanitaria dell'Alto Adige
Ospedale San Donato
Azienda Unita Sanitaria Locale di Piacenza
Policlinico Universitario, Catania
Fondazione Salvatore Maugeri
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, randomized, controlled, crossover, non-inferiority
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | T0 (baseline), T1 (+3months), T2 (+6months) | Unity of measurement: mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of PaO2 levels measured via arterial blood gas analysis | T0 (baseline), T1 (+3months), T2 (+6months) | Unit of measurement: mmHg |
| FVC, FEV1 | T0 (baseline), T1 (+3months), T2 (+6months) | Measured by spirometry Unit of measurement for FVC and FEV1: L |
| Evaluation of exercise capacity measured using the 6-minute walk test (6MWT) | T0 (baseline), T1 (+3months), T2 (+6months) | Unit of measurement: meters |
| Evaluation of dyspnea measured using the Medical Research Council Dyspnea score | aT0 (baseline), T1 (+3months), T2 (+6months) | mMRC score ranges from 0 to 4. 0=No dyspnea symptoms 4=severe dyspnea |
| Evaluation of quality of life measured using the St. George's Respiratory Questionnaire | T0 (baseline), T1 (+3months), T2 (+6months) | SGRQ's Total Score ranges between 0 and 100, where 0 is maximum quality of life and 100 is lowest quality of life |
| Evaluation of the time required for setting up and adjusting the two respiratory strategies. | T0 (baseline), T1 (+3months), T2 (+6months) | Unit of measurement: days |
| Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support. | T1 (+3months), T2 (+6months) | Time of usage of the respiratory support in hours/day and hours/night. |
| Evaluation of tolerance to respiratory supports meauserd using visual analog scales | T1 (+3months), T2 (+6months) | Visual analog scale ranges between 0 to 10, 0=minimum tolerance 10=maximum tolerance |
| Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred. | three, six and 12 month since the beginning of the treatment | Unit of measurement: number of events |
| Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations | T1 (+3months), T2 (+6months) and T3 (+12months) | Unity of measurement: number of exacerbation that required hospitalisation |
| Evaluation of survival measured by mortality analysis | T1 (+3months), T2 (+6months) and T3 (+12 months) | — |
| Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index | T0 (baseline), T1 (+3months), T2 (+6months) | PSQI ranges from 0 to 21, higher score indicate worse sleep quality |
Countries
Italy
Contacts
Primary ContactLara Pisani, Prof.ssa
Outcome results
None listed