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The imbalance between the prevalence of patients with acute respiratory failure (ARF) and acute-on-chronic respiratory failure and the number of intensive care unit (ICU) beds requires new solutions. The increasing use of non-invasive respiratory tools to support patients at earlier stages of ARF and the increased expertise of non-ICU clinicians in other types of supportive care have led to the development of adult pulmonary intensive care units (PICUs) and pulmonary intermediate care units (PIMCUs). As in other European countries, Italian PICUs and PIMCUs provide an intermediate level of care as the setting designed for managing ARF patients without severe non-pulmonary dysfunction. The PICUs and PIMCUs may also act as step-down units for weaning patients from prolonged mechanical ventilation and for discharging patients still requiring ventilatory support at home. These units may play an important role in the on-going coronavirus disease 2019 pandemic. This position paper promoted by the Italian Thoracic Society (ITS-AIPO) describes the models, facilities, staff, equipment, and operating methods of PICUs and PIMCUs.

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OBJECTIVE: Phytotherapeutic compounds are largely used in the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) due to low side-effect profiles and costs, high level of acceptance by patients and a low rate of dropout. Here, we aimed to analyze all available evidence on the role of Cucurbita pepo in the treatment of LUTS-BPH. MATERIAL AND METHODS: In May 2016 a systematic search was carried out thorough National Library of Medicine Pubmed, Scopus database and the ISI Web of Knowledge official website in order to identify all published studies on Cucurbita pepo and BPH. The following search strings were used: "Cucurbita pepo" OR "pumpkin seed" AND "prostate"; "Cucurbita pepo" AND "antiandrogen" OR "antiproliferative" OR "anti-inflammatory" OR "antioxidant activities"; "cucurbita pepo" OR "pumpkin seed" AND "LUTS" AND "symptoms improvement" OR "quality of life". We consider for the present analysis only studies related to LUTS-BPH. RESULTS: Among all 670 screened, 16 were related to LUTSBPH and finally analyzed. Among all, ten of them were performed in "in vitro setting" showing anti-inflammatory and antiandrogen effect, and a reduction in prostate growth and detrusor activity, while six were clinical studies. In all studies an improvement in International Prostatic Symptoms Score (IPSS) and uroflowmetry parameters has been reported. In 4 studies, an improvement in quality of life has been reported. CONCLUSION: On the basis of our narrative review, the use of Cucurbita pepo in the management of patients affected by LUTS-BPH seems to be useful for improving symptoms and quality of life. However, future clinical trials are requested to confirm these promising results.

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BACKGROUND: It has been suggested that withdrawal of inhaled corticosteroids (ICS) in COPD patients on maintenance treatment results in deterioration of symptoms, lung function and exacerbations. The aim of this real-life, prospective, multicentric study was to investigate whether withdrawal of ICS in COPD patients at low risk of exacerbation is linked to a deterioration in lung function and symptoms and to a higher frequency of exacerbations. METHODS: 914 COPD patients, on maintenance therapy with bronchodilators and ICS, FEV1>50% predicted, and <2 exacerbations/year were recruited. Upon decision of the primary physicians, 59% of patients continued their ICS treatment whereas in 41% of patients ICS were withdrawn and regular therapy was continued with long-acting bronchodilators mostly (91% of patients). FEV1, CAT (COPD Assessment Test), and occurrence of exacerbations were measured at the beginning (T0) and at the end (T6) of the 6 months observational period. RESULTS: 816 patients (89.3%) concluded the study. FEV1, CAT and exacerbations history were similar in the two groups (ICS and no ICS) at T0 and at T6. We did not observe any deterioration of lung function symptoms, and exacerbation rate between the two groups at T0 and T6. CONCLUSIONS: We conclude that the withdrawal of ICS, in COPD patients at low risk of exacerbation, can be safe provided that patients are left on maintenance treatment with long-acting bronchodilators.

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COPD is a chronic pathological condition of the respiratory system characterized by persistent and partially reversible airflow obstruction, to which variably contribute remodeling of bronchi (chronic bronchitis), bronchioles (small airway disease) and lung parenchyma (pulmonary emphysema). COPD can cause important systemic effects and be associated with complications and comorbidities. The diagnosis of COPD is based on the presence of respiratory symptoms and/or a history of exposure to risk factors, and the demonstration of airflow obstruction by spirometry. GARD of WHO has defined COPD "a preventable and treatable disease". The integration among general practitioner, chest physician as well as other specialists, whenever required, assures the best management of the COPD person, when specific targets to be achieved are well defined in a diagnostic and therapeutic route, previously designed and shared with appropriateness. The first-line pharmacologic treatment of COPD is represented by inhaled long-acting bronchodilators. In symptomatic patients, with pre-bronchodilator FEV1 < 60% predicted and ≥ 2 exacerbations/year, ICS may be added to LABA. The use of fixed-dose, single-inhaler combination may improve the adherence to treatment. Long term oxygen therapy (LTOT) is indicated in stable patients, at rest while receiving the best possible treatment, and exhibiting a PaO2 ≤ 55 mmHg (SO2 < 88%) or PaO2 values between 56 and 59 mmHg (SO2 < 89%) associated with pulmonary arterial hypertension, cor pulmonale, or edema of the lower limbs or hematocrit > 55%. Respiratory rehabilitation is addressed to patients with chronic respiratory disease in all stages of severity who report symptoms and limitation of their daily activity. It must be integrated in an individual patient tailored treatment as it improves dyspnea, exercise performance, and quality of life. Acute exacerbation of COPD is a sudden worsening of usual symptoms in a person with COPD, over and beyond normal daily variability that requires treatment modification. The pharmacologic therapy can be applied at home and includes the administration of drugs used during the stable phase by increasing the dose or modifying the route, and adding, whenever required, drugs as antibiotics or systemic corticosteroids. In case of patients who because of COPD severity and/or of exacerbations do not respond promptly to treatment at home hospital admission should be considered. Patients with "severe" or "very severe" COPD who experience exacerbations should be carried out in respiratory unit, based on the severity of acute respiratory failure. An integrated system is required in the community in order to ensure adequate treatments also outside acute care hospital settings and rehabilitation centers. This article is being simultaneously published in Sarcoidosis Vasc Diffuse Lung Dis 2014, 31(Suppl. 1);3-21.

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BACKGROUND: Several studies suggest that many asthmatic subjects have uncontrolled asthma. The control of asthma is now considered the major goal of therapy. OBJECTIVES: to ascertain the level of asthma control, by Asthma Control Test (ACT), in "real-life" clinical practice and the potential risk factors for uncontrolled disease in patients treated with inhaled corticosteroids (ICS) and long-acting beta-adrenergic agonists (LABA). METHODS: SERENA is a multi-centre, cross-sectional, 6-month observational, non-interventional study carried out in 16 Pulmonary Units in Italy. Asthmatic outpatients aged over 18, undergoing treatment with ICS at medium-high daily doses associated with LABA, were enrolled. The patients were divided in 3 subgroups according to the level of asthma control by ACT score (25:controlled; 20-24:partly controlled; <20: uncontrolled). RESULTS: Out of a total of 548 patients, 396 met the inclusion criteria. Only 9.1% of patients had asthma controlled, while partly controlled and uncontrolled asthma accounted for 39.6% and 51.3% respectively. The mean age was 54.5 ± 15.8 and the mean duration of asthma was 16.1 ± 14.1 years. There were more females than males (63% vs 37%) and females had highest prevalence of uncontrolled asthma (63.1%). The mean values of FEV1% predicted were lower in the uncontrolled group (p < 0.001). The percentage of patients with at least 1 exacerbation, unscheduled visit and/or admissions was lower in controlled (22.2%, 8.3%, 8.3%) than in partly controlled (50%, 38.6%, 9.2%) and uncontrolled (83.2%, 66.2%, 27.8%) groups (p < 0.0001). The multivariate ordinal logistic regression analysis identified female sex, FEV1 and exacerbations as the strongest independent factors associated with the uncontrolled disease. CONCLUSION: This study highlights the importance in clinical practice of a periodic assessment by a validated asthma control instrument and exacerbations/health care contacts during previous year. Clinicians should be aware that a significant proportion of patients can have uncontrolled asthma, despite regular pharmacological treatment.

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BACKGROUND: According to the GOLD international guidelines, the treatment of chronic obstructive pulmonary disease (COPD) should be proportional to the severity of airflow obstruction graded according to FEV(1)% predicted. Regular treatment with long-acting bronchodilators should be prescribed for symptomatic patients with FEV(1) < 80%. Inhaled corticosteroids should be added in patients with FEV(1) < 50% predicted and frequent exacerbations. AIM: To investigate whether pulmonologists follow the GOLD guidelines when prescribing treatment for COPD. METHODS: A multicenter, cross-sectional, observational study was carried out in 49 Pulmonary Units evenly distributed throughout the country. For each patient the demographic, clinical data and the current therapies were registered in an electronic database. RESULTS: 4094 patients (mean age: 70.9 ± 9.4; males 72.4%, female 27.6%) were enrolled. Disease severity was classified as: mild (745), moderate (1722), severe (923), very severe (704). Irrespective of disease severity, inhaled corticosteroids alone or in combination with long-acting bronchodilators were used in 15.2% and 66.8% of patients, respectively. The appropriateness of the pharmacological treatment of the COPD patients was defined in accordance with the GOLD recommendations. The treatment was appropriate in 37.9% of patients and inappropriate in 62.1%, p < 0.0001. The inappropriateness was due to under-prescription in 7.2% and to over-prescription in 54.9% of patients. The presence and the number of exacerbations represented an important trigger for over-prescription at stages I and II. CONCLUSIONS: This study shows that there is a poor relationship between the recommendations of the GOLD international guidelines and current clinical practice, and that exacerbations may play a role in over-prescription.

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INTRODUCTION: Recent experimental data suggest that continuous external negative-pressure ventilation (CENPV) results in better oxygenation and less lung injury than continuous positive-pressure ventilation (CPPV). The effects of CENPV on patients with acute respiratory distress syndrome (ARDS) remain unknown. METHODS: We compared 2 h CENPV in a tankrespirator ("iron lung") with 2 h CPPV. The six intubated patients developed ARDS after pulmonary thrombectomy (n = 1), aspiration (n = 3), sepsis (n = 1) or both (n = 1). We used a tidal volume of 6 ml/kg predicted body weight and matched lung volumes at end expiration. Haemodynamics were assessed using the pulse contour cardiac output (PiCCO) system, and pressure measurements were referenced to atmospheric pressure. RESULTS: CENPV resulted in better oxygenation compared to CPPV (median ratio of arterial oxygen pressure to fraction of inspired oxygen of 345 mmHg (minimum-maximum 183 to 438 mmHg) vs 256 mmHg (minimum-maximum 123 to 419 mmHg) (P < 0.05). Tank pressures were -32.5 cmH2O (minimum-maximum -30 to -43) at end inspiration and -15 cmH2O (minimum-maximum -15 to -19 cmH2O) at end expiration. NO Inspiratory transpulmonary pressures decreased (P = 0.04) and airway pressures were considerably lower at inspiration (-1.5 cmH2O (minimum-maximum -3 to 0 cmH2O) vs 34.5 cmH2O (minimum-maximum 30 to 47 cmH2O), P = 0.03) and expiration (4.5 cmH2O (minimum-maximum 2 to 5) vs 16 cmH2O (minimum-maximum 16 to 23), P =0.03). During CENPV, intraabdominal pressures decreased from 20.5 mmHg (12 to 30 mmHg) to 1 mmHg (minimum-maximum -7 to 5 mmHg) (P = 0.03). Arterial pressures decreased by approximately 10 mmHg and central venous pressures by 18 mmHg. Intrathoracic blood volume indices and cardiac indices increased at the initiation of CENPV by 15% and 20% (P < 0.05), respectively. Heart rate and extravascular lung water indices remained unchanged. CONCLUSIONS: CENPV with a tank respirator improved gas exchange in patients with ARDS at lower transpulmonary, airway and intraabdominal pressures and, at least initially improving haemodynamics. Our observations encourage the consideration of further studies on the physiological effects and the clinical effectiveness of CENPV in patients with ARDS.

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BACKGROUND: The imbalance between the increasing prevalence of acutely decompensated respiratory diseases and the shortage of intensive care unit beds has stimulated the growth of respiratory high-dependence care units (RHDCUs). METHODS: We conducted a national survey to analyze the changes, in the past 10 years, in the number, structures, staff, procedures, diagnoses, and outcomes in Italian RHDCUs that satisfy the European Respiratory Society's criteria (modified according to the Italian Association of Hospital Pneumologists) for high level (respiratory intensive care unit), intermediate level (respiratory intermediate intensive care unit), and low level (respiratory monitoring unit) RHDCU care. RESULTS: The number of RHDCUs increased from 26 to 44. The relative prevalence among all the RHDCUs increased only for the low-level units (P = .03). Compared to 1997, in 2007 a higher percentage of Italian RHDCUs were located within respiratory wards than located outside of respiratory wards (P = .03), and the physician-to-patient mean ratio and the nurse-to-patient mean ratio per shift were lower (P = .001 and P = .002, respectively). Admissions for only monitoring decreased (P < .001), and admissions for active interventions increased: noninvasive ventilation (P = .002), invasive ventilation (P < .001), weaning from invasive ventilation (P < .001), and tracheal decannulation (P < .001). The complexity of RHDCU patients' conditions increased: there was a reduction in the percentage of COPD patients (P < .001) and an increase in the percentage of patients with neuromyopathies (P < .001) and de novo hypoxemia (P = .006). CONCLUSIONS: Between 1997 and 2007 there was an increase in the number and expertise of Italian RHDCUs, with a shift toward less expensive care, and greater complexity of interventions and patient dysfunctions. These findings support the crucial role of RHDCUs in the management of respiratory critical patients.

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BACKGROUND: Tracheostomy is increasingly performed in intensive care units (ICU), with many patients transferred to respiratory ICU (RICU). Indications/timing for closing tracheostomy are discussed. AIM AND METHOD: We report results of a one-year survey evaluating: 1) clinical characteristics, types of tracheostomy, complications in patients admitted to Italian RICU in 2006; 2) clinical criteria and systems for performing decannulation, and outcome of patients undergoing tracheostomy (number decannulated; number non-decannulated/non-ventilated; number non-decannulated/ventilated; dead/lost patients). RESULTS: 22/32 RICUs replied. There were 846 admissions of 719 patients (Mean age 64,3 (+/-14.2) years, 489 (68%) males). Causes of admission were: acute respiratory failure with underlying chronic co-morbidities 176 (24.4%); exacerbation of Chronic Obstructive Pulmonary Disease 222 (34.4%); neuromuscular diseases 200 (27.8%); surgical patients 77 (10.7%); thoracic dysmorphism 28 (3.8%); obstructive sleep apnea syndrome 16 (2.2%). Percutaneous tracheostomies were 65.9%. Major complications after tracheostomy were 2%. 427 tracheostomies were evaluated for decannulation: 96 (22.5%) were closed; 175 patients (41%) were discharged with home mechanical ventilation; 114 patients (26.5%) maintained the tracheostomy despite weaning from mechanical ventilation and 42 patients (10%) died or lost. The clinical criteria chosen for decannulation were: stability of respiratory conditions, effective cough, underlying diseases and ability to swallow. The systems for evaluating feasibility of decannulation were: closure of tracheostomy tube; laryngo-tracheoscopy; use of tracheal button and down-sizing. CONCLUSIONS: There were few major complications of tracheostomy. A substantial proportion of patients maintain the tracheostomy despite not requiring mechanical ventilation. There was no agreement on indications and systems for closing tracheostomy.

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INTRODUCTION: To assess whether respiratory intermediate care units (RICUs) are cost effective alternatives to intensive care units (ICUs) for patients with exacerbation of chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Multi-centre, prospective, bottom-up cost study performed in 15 ICUs and 6 RICUs. COPD patients staying longer than 48 h were recruited; those coming from other ICUs/RICUs, with immune-deficiency or stroke, were excluded. After the ICU sample was standardised to the RICU distribution of the reason-for-admission and infusion of a vasoactive drug on admission, 60 ICU patients and 65 RICU patients remained, of the original 164 recruited. For each patient, besides clinical data on admission and discharge, daily information about the resources consumed were recorded and analysed in terms of their costs. RESULTS: Total cost per patient was lower in RICUs than in ICUs (754 vs. 1507 Euro; P < 0.0001). In all items, except drugs and nutrition, we found a significant lower cost in RICUs. Dead patients were noticeably different in terms of disease severity between ICUs and RICUs, while surviving ones were not. CONCLUSIONS: Our study suggests that some COPD patients, less severe and with pure respiratory failure, could be successfully and less costly treated in RICUs.

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OBJECTIVES: The efficacy of mechanical insufflation-exsufflation, in addition to standard chest physical treatments, was investigated as a first-line intervention for patients with neuromuscular diseases with respiratory tract infections and airway mucous encumbrance. DESIGN: The short-term outcomes of 11 consecutive neuromuscular disease patients with respiratory tract infections and tracheobronchial mucous encumbrance who were administered mechanical insufflation-exsufflation and conventional chest physical treatments in an intensive care unit were compared with the outcomes of 16 historical matched controls who had received chest physical treatments alone. Treatment failure was defined as the need for cricothyroid "minitracheostomy" or endotracheal intubation, despite treatment. The number of subjects administered bronchoscopy-assisted aspiration during the hospital stay was also compared. RESULTS: Treatment failure was significantly lower (P < 0.05) in the mechanical insufflation-exsufflation group than in the conventional chest physical treatments group (2/11 vs. 10/16 cases). The use of bronchoscopy-assisted aspiration was similar in the two groups (5/11 vs. 6/16 cases). Mechanical insufflation-exsufflation did not produce serious side effects and was well tolerated by all subjects. CONCLUSIONS: Provision of mechanical insufflation-exsufflation in combination with standard chest physical treatments may improve the management of airway mucous encumbrance in neuromyopathic patients; its use should be included in the noninvasive approach to treatment of respiratory tract infections with impaired mucous clearance.

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OBJECTIVE: To investigate in clinical practice the role of non-invasive mechanical ventilation in the treatment of acute respiratory failure on chronic respiratory disorders. DESIGN: An 18 months prospective cohort study. SETTING: A specialised respiratory intensive care unit in a university-affiliated hospital. PATIENTS: A total of 258 consecutive patients with acute respiratory failure on chronic respiratory disorders. INTERVENTIONS: Criteria for starting non-invasive mechanical ventilation and for endotracheal intubation were predefined. Non-invasive mechanical ventilation was provided by positive pressure (NPPV) ventilators or iron lung (NPV). RESULTS: The main characteristics of patients (70% with chronic obstructive pulmonary disease) on admission were (mean, SD or median, 25th-75th centiles): pH 7.29 (0.07), PaCO(2) 83 mm Hg (19), PaO(2)/FiO(2) 198 (77), APACHE II score 19 (15-24). Among the 258 patients, 200 (77%) were treated exclusively with non-invasive mechanical ventilation (40% with NPV, 23% with NPPV, and 14% with the sequential use of both), and 35 (14%) with invasive mechanical ventilation. In patients in whom NPV or NPPV failed, the sequential use of the alternative non-invasive ventilatory technique allowed a significant reduction in the failure of non-invasive mechanical ventilation (from 23.4 to 8.8%, p=0.002, and from 25.3 to 5%, p=0.0001, respectively). In patients as a whole, the hospital mortality (21%) was lower than that estimated by APACHE II score (28%). CONCLUSIONS: Using NPV and NPPV it was possible in clinical practice to avoid endotracheal intubation in the large majority of unselected patients with acute respiratory failure on chronic respiratory disorders needing ventilatory support. The sequential use of both modalities may increase further the effectiveness of non-invasive mechanical ventilation.

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BACKGROUND: Cardiovascular complications are frequently observed in patients with chronic obstructive pulmonary disease (COPD) admitted to respiratory intensive care units and may affect the prognosis. The aims of this study were to evaluate a) the prevalence of cardiovascular complications in patients with COPD exacerbation admitted to respiratory intensive care units, b) which parameters detected at admission were predictive of cardiovascular complications, and c) the prognostic role of cardiovascular complications. METHODS: A series of 278 consecutive patients with COPD admitted to 11 Italian respiratory intensive care units between November 1997 and January 1998 has been retrospectively analyzed. All cardiovascular complications were recorded. RESULTS: One hundred and ten patients (39.6%) developed cardiovascular complications: congestive heart failure 49 (17.6%), arrhythmias 40 (14.4%), shock 13 (4.7%), and hypotension 11 (4%). Multivariate analysis showed that the APACHE II score, ECG abnormalities (supraventricular ectopic beats, right and/or left ventricular hypertrophy) and digoxin therapy were independent predictors of cardiovascular complications. The overall mortality was 9% being 4.7% in patients without and 15.5% in patients with cardiovascular complications (p = 0.0044). Multivariate analysis showed that the APACHE II score, respiratory rate, pneumonia and end-stage respiratory diseases were independent predictors of mortality. CONCLUSIONS: Cardiovascular complications occurred in many patients with COPD exacerbation admitted to respiratory intensive care units, and identify a subset of patients with higher mortality.

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STUDY OBJECTIVES: Evaluation of the effectiveness of negative-pressure ventilation (NPV) with the use of the iron lung vs noninvasive positive-pressure ventilation (NIPPV) in the treatment of COPD patients with acute on chronic respiratory failure. DESIGN: A retrospective case-control study. SETTING: Four Italian respiratory intermediate ICUs. PATIENTS: Of a total of 393 COPD patients admitted to the ICU in 1996, 53 pairs were treated with the iron lung (NPV group). Patients treated with NIPPV (NIPPV group) were matched according to mean (+/- SD) age (70.3 +/- 7.1 vs 70.3 +/- 6.9 years, respectively), sex, causes of acute respiratory failure (ARF), APACHE (acute physiology and chronic health evaluation) II score (22.4 +/- 5.3 vs 22.1 +/- 4.6, respectively), pH (7.26 +/- 0.05 vs 7.27 +/- 0.04, respectively), and PaCO(2) (88.1 +/- 11.5 vs 85.1 +/- 13.5 mm Hg, respectively) on admission to the ICU. The effectiveness of matching was 98.4%. RESULTS: Five patients from the NPV group (9.4%) and seven patients from the NIPPV group (13.2%) needed endotracheal intubation (EI). The treatment failure rate (ie, death and/or need of EI) was 20.7% in the NPV group and 24.5% in the NIPPV group (difference was not significant). The mean duration of mechanical ventilation (29.6 +/- 28.6 vs 62.3 +/- 35.7 h, respectively) and length of hospital stay (10.4 +/- 4.3 vs 15 +/- 5.2 d, respectively) among the 35 concordant surviving pairs were significantly lower in the NPV group than in the NIPPV group (p = 0.001 and p = 0.001, respectively). CONCLUSIONS: These data suggest that both ventilatory techniques are equally effective in avoiding EI and death in COPD patients with ARF. Prospective trials are needed to confirm these preliminary results.

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Noninvasive mechanical ventilatory techniques include the use of negative and positive pressure ventilators. Negative pressure ventilators support ventilation by exposing the surface of the chest wall to subatmospheric pressure during inspiration, whereas expiration occurs when the pressure around the chest wall increases and becomes equal to or greater than atmospheric pressure. In this article, a description of negative pressure ventilators and the physiologic effects of negative pressure ventilation (NPV) is given, and the application of this technique in the long-term treatment of chronic respiratory failure is summarized. Many studies, although uncontrolled, have shown that long-term treatment with NPV can improve respiratory muscle function, arterial blood gases, and survival in patients with neuromuscular and chest wall disorders. NPV devices, however, are more cumbersome and difficult to use than home positive pressure ventilators (PPVs) and tend to predispose to obstructive apnoeas during sleep. In the last several decades, NPV has been supplanted by mask PPV. In experienced hands, NPV remains a second viable option in patients with neuromuscular and chest wall disorders who, for technical or other reasons, cannot be offered mask PPV. There is no evidence, however, that long-term treatment with NPV can improve respiratory muscle function, exercise endurance, quality of life, and survival in patients with severe chronic obstructive pulmonary disease.

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