Effectiveness of a new "focused pulse" high-frequency chest wall oscillation in patients with moderate to severe COPD.

BACKGROUND: Chest physiotherapy plays a crucial role in the treatment of COPD, although the optimal techniques for airway clearance have not been definitively established. Among the different techniques, high-frequency chest wall oscillation (HFCWO) has gained attention for its potential to create a widespread lung percussion, facilitating the removal of secretions and potentially clearing the peripheral bronchial tree. This study aims to assess the effectiveness of a novel "focused pulse" HFCWO in patients with moderate to severe COPD. METHODS: Sixty patients were randomized to three groups: a group treated with the PEP technique, a group with "focused pulse "HFCWO" and a group with pharmacological therapy alone (control group). The primary outcomes were changes in respiratory function parameters, changes in dyspnea and quality of life scores as well as daily life activity and health status assessment. The secondary outcomes were the number of exacerbations and the number of practitioner or emergency department (ED) visits after 1, 3, and 6 months. RESULTS: Sixty patients concluded the study with 20 patients allocated to each group. The two devices improved respiratory function tests, quality of life and health scores and dyspnea compared to the control group. Maximal expiratory pressure and diffusing lung carbon oxide were significantly improved in the focused pulse HFCWO group compared to the PEP group. Only pulse-focused HFCWO showed a statistically significant lower number of exacerbations and visits to ED or practitioner compared to the control group. CONCLUSIONS: The focused pulse HFCWO technique improves daily life activities and lung function in patients with stable COPD. The device demonstrated significantly greater effectiveness in lowering COPD exacerbations as well as visits to ED or practitioner.

The pathogenesis of OSA-related hypertension: what are the determining factors?

Sleep-disordered breathing has a relatively high prevalence, which varies from 3-7% in males and from 2-5% in females in the adult population. Studies published in the literature have shown that sleep apnea is closely related to an increased risk of developing various pathologies, among which arterial hypertension stands out. The prevalence of hypertension in patients suffering from obstructive sleep apnea (OSA) ranges from 35-80% and appears to be related to OSA severity. Approximately 40-50% of patients affected by hypertension are also affected by OSA and this association seems to be stronger in young and middle-aged adults (<50 years of age). The primary objective of this narrative review is to provide an update on what are the main contributing comorbidities to the development of a hypertensive state in patients suffering from OSA, an independent risk factor for diurnal hypertension, implicated as a risk factor for the first stroke, recurrent stroke, and post-stroke mortality. There are a lot of factors that contribute to developing a hypertensive state in OSA patients, some more decisive, others less. More evidence from longitudinal studies is needed on the impact of OSA on cardiovascular risk in females, on the causal link between OSA and arterial hypertension or metabolic diseases, like diabetes and glucose intolerance, and the effect of different kinds of OSA treatment.

Is Intermittent Abdominal Pressure Ventilation Still Relevant? A Multicenter Retrospective Pilot Study.

Non-invasive ventilatory support (NVS) is a technique used to reduce respiratory work in neuromuscular diseases, preventing the progression of respiratory failure. NVS is usually administered via a nasal or an oronasal mask, causing discomfort, especially in patients ventilated for more than 16 h/day. Intermittent abdominal pressure ventilation (IAPV) differs completely from conventional NVS and consists of a portable ventilator and a corset with Velcro closures as the interface. In our study, the practicability and efficacy of IAPV were studied in three Italian centers monitoring 28 neuromuscular patients using IAPV who were then retrospectively analyzed. The primary outcomes were an improvement in hypoxemia and the normalization of hypercapnia, and the secondary outcome was an improvement in quality of life. Data were collected at baseline (T0) and after two hours of ventilation (T1), with follow-ups at three months (T2) and six months (T3). Statistical significance was found for PaCO2 over time (F (2.42) = 7.63, p = 0.001) and PaO2 (W = 0.539, p = 0.033). The time of NVS usage also significantly affected the quality of life (F (2.14) = 6.90, p = 0.010), as seen when comparing T0 and T3. As an alternative ventilation method, IAPV is still relevant today and could become a key part of daytime support, especially for patients who do not tolerate standard daytime NVS with an oral interface.

Gender differences in obesity hypoventilation syndrome.

Sleep-disordered breathing (SDB) is a group of sleep-related breathing disorders which includes obstructive sleep apnea (OSA), central sleep apnea (CSA), and obesity hypoventilation syndrome (OHS). OHS is characterized by a combination of obesity, daytime hypercapnia and hypoxemia, and sleep-disordered breathing without other known hypoventilation causes, such as severe obstructive or restrictive parenchymal lung disease, kyphoscoliosis, severe hypothyroidism, neuromuscular disease, or congenital central hypoventilation syndrome. Four hundred ninety potentially eligible references were identified; of these, 462 abstracts or full texts were excluded because they did not fulfil inclusion criteria. We reviewed the full text of the remaining 38 papers which fulfilled the inclusion criteria. The role of gender in SDB and particularly in OHS is not well known. In general, the diseases are under-recognized in women and only a few studies have reported the impact of gender on clinical presentation and treatment outcome. On the other hand, there is often a delay in diagnosing these diseases in women as compared to men; therefore, they are often more advanced when diagnosed in women. Better understanding and clinical awareness of the higher OHS prevalence in postmenopausal women may lead to earlier diagnosis and a more timely and appropriate treatment. Further studies are needed to assess the prevalence of OHS in women, the effect of menopause on OHS, and the increased risk of OHS, which will hopefully lead to optimizing OHS patient care.

Mandibular Torus as a New Index of Success for Mandibular Advancement Devices.

BACKGROUND: In obstructive sleep apnoea (OSA), treatment with mandibular advancement devices (MADs) reduces patients' Apnoea-Hypopnoea index (AHI) scores and improves their sleepiness and quality of life. MADs are non-invasive alternatives for patients who cannot tolerate traditional continuous positive airway pressure (CPAP) therapy. The variability of responses to these devices makes it necessary to search for predictors of success. The aim of our study was to evaluate the presence of mandibular torus as a predictor of MAD efficacy in OSA and to identify other potential cephalometric factors that could influence the response to treatment. METHODS: This was a retrospective cohort study. The study included 103 patients diagnosed of OSA who met the criteria for initiation of treatment with MAD. Structural variables were collected (cephalometric and the presence or absence of mandibular torus). Statistical analysis was performed to evaluate the existence of predictive factors for the efficacy of MADs. RESULTS: A total of 103 patients who were consecutively referred for treatment with MAD were included (89.3% men); the mean age of the participants was 46.3 years, and the mean AHI before MAD was 31.4 (SD 16.2) and post- MAD 11.3 (SD 9.2). Thirty-three percent of patients had mandibular torus. Torus was associated with a better response (odds ratio (OR) = 2.854 (p = 0.035)) after adjustment for sex, age, body mass index (BMI; kg/m2), the angle formed by the occlusal plane to the sella-nasion plane (OCC plane to SN), overinjection, and smoking. No cephalometric predictors of efficacy were found that were predictive of MAD treatment success. CONCLUSIONS: The presence of a mandibular torus practically triples the probability of MAD success. This is the simplest examination with the greatest benefits in terms of the efficacy of MAD treatment for OSA.

Efficacy of Nasal High-Flow Oxygen Therapy in Chronic Obstructive Pulmonary Disease Patients in Long-Term Oxygen and Nocturnal Non-Invasive Ventilation during Exercise Training.

High-flow oxygen therapy (HFOT) improves gas exchange and dead space washout and reduces the level of work required for breathing. This study aimed to evaluate pulmonary rehabilitation (PR) combined with HFOT in COPD patients treated with nocturnal non-invasive ventilation (NIV) and long-term oxygen therapy (LTOT). In particular, we sought to discover whether the addition of HFOT during exercise training could improve patients' performance, mainly with regard to their Six-Minute Walking Test (6MWT) outcomes, and reduce the exacerbation rates, periods of rehospitalization or need to resort to unscheduled visits. Thirty-one COPD subjects (13 female) who used nocturnal NIV were included in a randomized controlled trial and allocated to one of two groups: the experimental group (EG), with 15 subjects, subjected to PR with HFOT; and the control group (CG), with 16 subjects, subjected to PR without HFOT. The primary outcome of the study was the observation of changes in the 6MWT. The secondary outcome of the study was related to the rate of exacerbation and hospitalization. Data were collected at baseline and after one, two and three cycles of cycle-ergometer exercise training performed in 20 supervised sessions of 40 min thrice per week, with a washout period of 3 months between each rehabilitation cycle. Statistical significance was not found for the 6MWT distance (W = 0.974; p = 0.672) at the last follow-up, but statistical significance was found for the Borg scale in regard to dyspnea (W = 2.50; p < 0.001) and fatigue (W = 2.00; p < 0.001). HFOT may offer a positive option for dyspnea-affected COPD patients in the context of LTOT and nocturnal NIV.

Risk factors in developing retinal vein occlusion in subject with obstructive sleep apnea.

BACKGROUND: Patients with obstructive sleep apnoea (OSA) have a higher risk of developing vascular diseases. In this study, we evaluated the clinical profile of patients with OSA who develop Retinal Vein Occlusion (RVO) compared with a population of OSA patients without RVO. METHODS: We analysed patients with OSA diagnosed with RVO (21 cases; mean of age 61 (12) yrs. range 44-87 yrs. 67% men), belonging to a large cohort of people with long-term follow-up for RVO (up to 12 years). We compared them with 21 patients with OSA, without RVO, matched by age and gender, selected from the Sleep Unit Registry (control group). RESULTS: There were no differences in the prevalence of arterial hypertension (AHT) or Diabetes mellitus (DM), but the RVO patients presented a higher diastolic blood pressure compared to controls (87.6±12.6 mmHg vs. 77.9±10.1 mm Hg respectively). The polygraphic parameters were similar in both groups. The Apnoea-Hypopnoea Index (IHA) similar in both groups (30.4 ±20.9 RVO vs. 33.7 ± 22.1 controls). In addition, RVO patients had a less favourable lipid profile, with higher total cholesterol (218±52 mg/dL vs. 179±41 mg/dL), higher LDL cholesterol (139±47 mg/dL vs. 107±32 mg/dL) and higher atherogenic indices: LDL/HDL (2.78 ± 0.95 RVO vs. 2.03±0.67 controls) and total cholesterol / HDL (4.37± 1.08 vs. 3.45 ± 0.84). Among the cases, 81% had peripheral RVO (superior temporal branch in 20 out of 21 cases) and 19% had central RVO. 62% of the cases received intravitreal antiangiogenic therapy and dexamethasone implants and 33% received argon laser photocoagulation. CONCLUSIONS: Poor control of cardiovascular risk factors, particularly dyslipidaemias, in patients with OSA may lead to the development of this ocular complication.

Effectiveness of two high-frequency chest wall oscillation techniques in patients with bronchiectasis: a randomized controlled preliminary study.

BACKGROUND: Chest physiotherapy is an important tool in the treatment of bronchiectasis. High-frequency chest wall oscillation (HFCWO) is a technique designed to create a global percussion of the lung which moves secretions and probably clears the peripheral bronchial tree. We propose the comparison between an existing device (SmartVest) and a new device (RespIn 11). METHODS: Sixty patients were randomized into three groups: a group was treated with SmartVest, a group with RespIn 11, and a group with pharmacological therapy alone. Primary outcome measures included exacerbations at 3, 6 and 12 months after the end of treatment. Secondary outcome measures were pulmonary function testing, arterial blood gas analysis (ABG), and hematological examinations, cough, dyspnea, health and quality of life scores (Bronchiectasis Health Questionnaire [BHQ], Breathlessness, Cough, and Sputum Scale [BCSS], COPD Assessment Test [CAT], Leicester Cough Questionnaire [LCT]). A five-point Likert Scale was used to evaluate patient's preference. RESULTS: Both patients in the HFCWO groups showed a significant improvement in the tests of dyspnea, cough and health and quality of life score evaluations (BHQ, BCSS, CAT, LCT) compared to the control group, but not in pulmonary function tests and ABG. Only RespIn 11 significantly reduced exacerbations in comparison with the control group. RespIn 11 also had a higher score regarding patients' preference. CONCLUSIONS: The two machines have improved health and quality of life scores in patients with bronchiectasis. RespIn 11 also demonstrated a significant lowering of exacerbations and a better patient acceptance.

Comparison of two mechanical insufflation-exsufflation devices in patients with amyotrophic lateral sclerosis: a preliminary study.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease affecting upper and lower motor neurons and resulting in progressive skeletal muscle weakness. Weak cough and difficulty in clearing secretions are often the cause of pulmonary infections and acute respiratory failure. Cough assistance is commonly used to provide support in coughing for patients with ALS. METHODS: This was a preliminary parallel randomized study comparing two cough-assist devices: one utilizing mechanical insufflation/exsufflation (MI/E) and expiratory flow accelerator (EFA) technology, the other utilizing only MI/E technology. The aim was to compare the effectiveness, safety and acceptability of the two devices. Thirty patients with ALS and similar severity and functional scale were enrolled. The primary outcome was the change in respiratory function, respiratory muscle function, gas exchange, and peak cough expiratory flow as an indicator of cough efficacy. Secondary outcomes were the number of exacerbations at 1, 6 and 12 months of treatment, and the patient-perceived comfort/distress related to the interventions together with the perceived efficacy of cough. RESULTS: Thirty subjects were recruited and randomized into the two groups (1:1 ratio). Primary outcomes : respiratory function parameters decreased over time in both groups, but significantly less in the Kalos group, as did the respiratory muscle strength parameters and peak cough flows. Gas exchanges decreased over time in both groups with no clinically relevant differences between groups. Secondary outcomes : there were no significant differences between groups regarding the number of exacerbations over time. No adverse events were reported. All participants, in both groups, reported a similar increase in perceived cough efficacy and there was no significant difference in comfort and distress between the two treatments. CONCLUSIONS: The cough-assist device with EFA technology performed better than a traditional MI/E device in ALS patients regarding respiratory function and cough efficacy, although number of exacerbations and acceptability of the two devices was similar. Following these promising preliminary results, further investigation is required in a larger cohort to confirm the superiority of EFA technology associated with a MI/E device.

Differences between sexes concerning COVID-19-related pneumonia.

BACKGROUND: Pneumonia is both the most common type of lower respiratory tract infection and a major cause of morbidity and mortality worldwide. The COVID-19 pandemic caused by the SARS-CoV-2 raised an extremely serious concern, because its most frequent clinical presentation was pneumonia. Features such as sex play an active role in the incidence and outcomes of pneumonia. This study aimed to evaluate differences between sexes concerning COVID-19-related pneumonia. METHODS: This was a retrospective, multicenter study that enrolled 340 consecutive adult patients admitted to hospital for COVID-19-related pneumonia. Of these patients, 219 were males (64.4%) and 121, females (35.6%). Primary endpoints were differences between both sexes as per clinical features, laboratory and radiologic results, and in-hospital and 30-day mortality. Secondary outcomes included differences between both sexes and factors associated with mortality. RESULTS: Males admitted to the COVID-19 Unit were older than females (74.5±15.7 vs. 64.5±11.9). Cardiovascular disorders were more frequent in males (19.17% vs. 13.25%), whereas obesity was more common in females (54.5% vs. 37.45%). In-hospital and 30-day mortality were higher in males than in females (23.3% vs. 15.7%; 24.6% vs. 19.8%, respectively). No differences were observed in hospital stay; however, males had a longer ICU stay when compared with females (11.04±5.4 vs. 7.05±3.4). Variables associated with a higher mortality rate included older age, a lower number of lymphocytes upon admission and higher levels of ferritin and troponin upon admission. CONCLUSIONS: Males had significantly higher mortality and longer ICU stay than females. More comorbidities in males than in females could explain the difference in mortality rates. The protective role of genetic factors can partially explain the better outcomes observed in female patients with COVID-19.

Do not forget the lungs: preliminary feasibility study on I/E mode physiotherapy for people recovering from COVID-19.

BACKGROUND: Early chest physiotherapy is recommended for patients with post-COVID syndrome to improve dyspnea, relieve anxiety, minimize disability, preserve lung function and improve Quality of Life. However, there is still no consensus on the best treatments to manage respiratory symptoms. We aimed to test a method based on a guided in/expiratory (I/E) modulation to treat the lung inhomogeneity. METHODS: Twenty patients with post-COVID syndrome and mild-to-moderate obstructive syndrome performed 3 15-min sessions/day using the I/E mode of the T-PEP®4 device (Medical Products Research Srl, Legnano, Milan, Italy), for 15 consecutive days. Lung function parameters, dyspnea, and Quality of Life scores, as well as exercise capacity were assessed before and after treatment. RESULTS: All patients concluded the treatment and showed significant improvements in symptoms (chest pain during deep inspiration, chest tightness, inability to yawn, fatigue during activities of daily living [ADL], desaturation ≥4% during ADL) and in health status (BCSS -1.75, P=0.0003; CAT -5.2, P=0.0001). Lung function (FVC +10.9%, P=0.0002; FEV1 +8%, P=0.0001) and respiratory muscle strength (MIP +13.8%, P<0.0001; SNIP +13.6%, P=0.0122; MEP +7.6%, P=0.0045) improved. Exercise capacity also improved (6MWT +14.2%, P=0.005). At the end of treatment, only 2 patients reported symptoms and ADL-induced desaturation, while 14 still had fatigue during ADL. CONCLUSIONS: This study shows that chest physiotherapy using an I/E device to actively recruit peripheral lungs in COVID-19 patients early after hospital discharge improved lung function tests as well as respiratory muscle strength, exercise capacity and Quality of Life.

Intermittent abdominal pressure ventilation: feasibility and efficacy in neuromuscular disease. A case report.

The standard treatment for patients with neuromuscular respiratory failure is non-invasive ventilation (NIV) as non-invasive ventilation support-setting (NVS). NVS is administered through a nasal or face mask and/or mouthpiece with the potential to cause nasal ulcers, discomfort, and/or aesthetic issues, resulting in poor compliance. We reported the observation of a 45-year-old woman with limb-girdle muscular dystrophy (LGMD), secondary to Dysferlin deficiency, who was on NVS since 2017 for nocturnal hypoventilation. In 2018, despite nocturnal ventilation, due to weight gain and daytime hypoventilation, a nasal mask was introduced. We initiated daytime intermittent abdominal pressure ventilation (IAPV) to mitigate cosmetic problems, improving in pO2 and decreasing in pCO2 versus baseline (52>84 mmHg, 46>33 mmHg respectively) at 6 (85 mmHg, 42 mmHg) and 18 months (93 mmHg, 38 mmHg), respectively. IAPV was effective, safe, and well-tolerated in our patients who did not tolerate standard daytime NVS with the known interface.

Pneumomediastinum associated with severe pneumonia related to COVID-19: diagnosis and management.

BACKGROUND: Pneumomediastinum (PNM) can develop as a severe complication of severe COVID-19 and may be correlated with greater morbidity and mortality. PNM is a rarely reported complication in COVID-19 patients and usually associated with endotracheal intubation. METHODS: Our aim was to describe the characteristics of patients with PNM in twenty-one patients with COVID-19 related pneumonia and acute respiratory failure in a retrospective case series. RESULTS: Twenty-one patients were diagnosed, four were treated with high-flow nasal cannula, thirteen with non invasive ventilation and four with invasive mechanical ventilation. In five cases PNM was massive and associated to subcutaneous emphysema; more rarely PNM was associated with pneumothorax. Conservative management was the most used therapeutic strategy. CONCLUSIONS: PNM is a serious and not extremely rare complication of severe forms of pulmonary involvement of COVID-19. The clinician should consider this rare complication; moreover, we suggest being careful when clinicians start mechanical ventilation.

Comparison of an expiratory flow accelerator device versus positive expiratory pressure for tracheobronchial airway clearance after lung cancer lobectomy: a preliminary study.

OBJECTIVE: A new type of device has recently been introduced in chest physiotherapy as an aid to tracheo-bronchial airway clearance: expiratory flow accelerator (EFA). It promotes mucus clearance without generating any pressure gradient, allowing patients to breathe at tidal volume against no resistance. DESIGN: Pilot randomized controlled study. SETTING: Tertiary hospital. PARTICIPANTS: Fifty adult patients who underwent lung cancer lobectomy were randomized to undergo chest physiotherapy with EFA (n=26) or PEP (n=24). INTERVENTIONS: EFA; PEP bottle. MAIN OUTCOMES: Incidence of postoperative pulmonary complications (PPC) and length of stay. SECONDARY OUTCOMES: trends in inspiratory capacity, respiratory rate, oxygen saturation, and dyspnoea. Patients rated user-friendliness of the two devices on a 5-point Likert scale. RESULTS: A slightly different incidence of PPCs was observed between the EFA and PEP group. Nevertheless, the length of stay was similar in the two groups. No substantial differences were seen in trends of inspiratory capacity, respiratory rate, oxygen saturation, dyspnoea between the two groups. Patient-reported user-friendliness of the two devices did not differ significantly, although the use of the EFA device appeared less strenuous. CONCLUSIONS: Results of this pilot study point to the use of EFA as an alternative treatment option rather than as a replacement for the PEP bottle in chest physiotherapy following lung cancer lobectomy. EFA may be preferable for weaker patients and/or with airway leakages in whom PEP has limited indications. Further investigation in a larger sample is required to statistically confirm the findings. Clinical Trial Registration Number ChiCTR-ONC-17013255.

Management of patients with severe acute respiratory failure due to SARS-CoV-2 pneumonia with noninvasive ventilatory support outside Intensive Care Unit.

BACKGROUND: COVID-19 has high mortality rate mainly stemming from acute respiratory distress leading to respiratory failure (ARF). Aim of the study was to evaluate the management of severe ARF due to COVID-19 pneumonia using noninvasive ventilatory support (NIVS), studying safety and effectiveness of NIVS. METHODS: This is a retrospective, multicenter study. Primary outcomes were NIVS failure with intubation rate and hospital mortality. Secondary outcomes were hospital stay and factors related to NIVS failure and mortality. These outcomes were compared with patients intubated and admitted to ICU. RESULTS: One hundred sixty-two patients were hospitalized because of severe respiratory failure (PaO2/FiO2 ratio <250). One hundred thirty-eight patients were admitted to Respiratory Intermediate Care Unit (RICU) for a NIVS trial. One hundred patients were treated successfully with NIVS (74.5%); 38 failed NIVS trial (27.5%). In-hospital mortality was 23.18% in RICU group and 30.55% in ICU group. Patients with NIVS failure were older, had a lower number of lymphocytes, a higher IL-6, lower PaO2, PaC O2, PaO2/FiO2 ratio, higher respiratory rate (RR) and heart rate at admission and lower PaO2, and PaO2/FiO2 ratio and higher RR after 1-6 hours. Multivariate analysis identified higher age, C-reactive protein as well as RR after 1-6 hours and PaO2/FiO2 ratio after 1-6 hours as an independent predictor mortality. CONCLUSIONS: NIVS is a safe and effective strategy in the treatment of severe ARF due to COVID-19 related pneumonia, that reduces mortality and length of hospital stay in the carefully selected patients.

High-Flow Nasal Oxygen Therapy in Acute Hypoxemic Respiratory Failure: Concise Review on Technology and Initial Methodology.

High-flow nasal cannula oxygen therapy (HFNCOT) system consists of an air/oxygen supply system capable of delivering up to 100% humidified and heated oxygen at a flow rate of up to 80 L/min. The system includes a blender, active humidifier, single heated tube, and nasal cannula. HFNCOT has many physiological advantages compared with other standard oxygen therapies, such as anatomical dead space washout, more constant fraction of inspired oxygen, positive end-expiratory (PEEP) effect, supplement of adequate humidification and maintenance of muco-ciliary function. HFNCOT is mostly used for hypoxemic acute respiratory failure, although it also has other indications. HFNCOT is a common choice of physicians as its technology makes it more silent and comfortable. Though HFNCOT is used in many clinical settings, there is a lack of publications addressing devices and initial settings. We present a review on HFNCOT, with focus on device and application methodology.

Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.

OBJECTIVES: Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception. MATERIALS AND METHODS: Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS). RESULTS: Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV1, FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS). CONCLUSION: The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.