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BACKGROUND: Laboratory studies suggest applying positive pressure without endotracheal suction during cuff deflation and extubation. Although some studies reported better physiological outcomes (e.g. arterial blood gases) with this technique, the safety of positive pressure extubation technique has not been well studied. The aim of this study was to determine the safety of the positive-pressure extubation technique compared with the traditional extubation technique in terms of incidence of complications. METHODS: Adult subjects who were critically ill and on invasive mechanical ventilation who met extubation criteria were included. The subjects were randomly assigned to positive-pressure extubation (n = 120) or to traditional extubation (n = 120). Sequential tests for noninferiority and, when appropriate, for superiority were performed. Positive pressure was considered noninferior if the upper limit of the CI for the absolute risk difference did not exceed a threshold of 15% in favor of the traditional group, both in per protocol and intention-to-treat analyses. A P value of RESULTS: A total of 236 subjects were included in the primary analysis (per protocol) (119 in the positive-pressure group and 117 in the traditional group). The incidence of overall major and minor complications, pneumonia, extubation failure, and reintubation was lower in the positive-pressure group than in the traditional group, with statistical significance for noninferiority both in the per protocol (P CONCLUSIONS: Positive pressure was safe and noninferior to traditional extubation methods. Furthermore, positive pressure has shown to be superior in terms of a lower incidence of major complications. (ClinicalTrials.gov registration NCT03174509.)

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease of unknown etiology and pathogenic mechanisms. From an etiopathogenic point of view, alveolar macrophages play a key role in accumulation of fibroblasts and deposition of collagen and extracellular matrix by releasing specific cytokines and inflammatory mediators. IPF seems to be also associated with circulating fibrocytes, which might be involved with an abnormal pulmonary vascular repair and remodeling. Based on its hypothesized pathologic mechanisms, anti-inflammatory, anti-fibrotic and immunosuppressive therapies are often used. For these reasons, Interferon-g (IFN-g) has been used to exploit its activity on macrophages and fibroblasts. The aim of this study was to investigate the response to corticosteroids and/or IFN-g 1b treatments based on pulmonary function tests and on inflammatory cytokine patterns of expression on bronchoalveolar lavage (BAL), at baseline and during and after the therapies. Unlike previous studies, we analyzed a period of therapy longer than 1 year. Our results demonstrated the effectiveness of IFN-γ in a group of IPF patients in whom the treatment was prolonged for over a year. These data suggest a positive role of IFN-γ; treatment in patients in the initial stage of the disease.

Background The aim of the present study was to investigate how auditory background interacts with learning and memory. Both facilitatory (e.g., “Mozart effect”) and interfering effects of background have been reported, depending on the type of auditory stimulation and of concurrent cognitive tasks. Method Here we recorded event related potentials (ERPs) during face encoding followed by an old/new memory test to investigate the effect of listening to classical music (Cajkovskij, dramatic), environmental sounds (rain) or silence on learning. Participants were 15 healthy non-musician university students. Almost 400 (previously unknown) faces of women and men of various age were presented. Results Listening to music during study led to a better encoding of faces as indexed by an increased Anterior Negativity. The FN400 response recorded during the memory test showed a gradient in its amplitude reflecting face familiarity. FN400 was larger to new than old faces, and to faces studied during rain sound listening and silence than music listening. Conclusion The results indicate that listening to music enhances memory recollection of faces by merging with visual information. A swLORETA analysis showed the main involvement of Superior Temporal Gyrus (STG) and medial frontal gyrus in the integration of audio-visual information.

Objective Exacerbations of COPD cause a huge consumption of healthcare resources. Aim of the ICE study is to estimate direct and indirect costs for COPD exacerbations admitted to hospital.

Thiamphenicol is a broad-spectrum antimicrobial agent active against penicillin-resistant Streptococcus pneumoniae, Staphylococcus aureus VISA strains, most methicillin-resistant isolates and atypical pathogens such as Mycoplasma pneumoniae and Chlamydia pneumoniae). Thiamphenicol is present as glycinate hydrochloride (TG) and glycinate acetylcysteinate (TGA) esters in the parenteral and aerosol dosage form. This multicenter, double-blind, randomized clinical trial aimed to evaluate the efficacy and tolerability of aerosol administration of TGA, compared to TG, in the treatment of acute and/or exacerbated infections of the respiratory tract. Results showed that both treatments ameliorated the symptoms (frequency and severity of cough, difficulty in expectoration) associated with the evaluated pathologies, i.e. tracheobronchitis, acute and exacerbated chronic bronchitis. The investigators rated both treatments Good or Very Good in 90% of patients at the end of treatment, with "Very Good" for patients treated with TGA (37%) compared to 28% of patients treated with TG. Both treatments were well tolerated with fewer than 5% of patients experiencing an adverse event.

This study aimed to evaluate the incidence of Chlamydophila pneumoniae antibodies in patients with community acquired pneumonia (CAP) by a new ELISA test (EIA CP-IgG, IgA, IgM--Eurospital, Trieste, Italy). From January 1999 to July 2001 141 patients with clinical signs of CAP were enrolled in sixteen Italian Hospitals. Specific IgM and IgG antibodies anti-C. pneumoniae in serum and IgA in both serum and sputum were detected. At a primary inspection (time T-0) serum and sputum samples were taken from 115/141 patients, whereas serum was collected from only 100/141 patients after 30 days (time T-30). At T-0 24/115 (20.8%) patients showed serological markers thus suggesting an acute C. pneumoniae infection. In 23/24 patients the overall serological pattern found at T-0 was confirmed at T-30. In 32/115 patients (27.8%) serological markers of C. pneumoniae past infection were found positive and were confirmed 30 days later. These data support the role of C. pneumoniae as an important aetiological agent of CAP throughout different geographic areas of Italy. The test was suitable for the laboratory diagnosis of C. pneumoniae infection. In particular, the presence of specific IgA anti- C. pneumoniae in both serum and sputum proved useful to define different stages and evolution of infection.

Asthma represents a growing public health problem and the cost of asthma has been rising in many countries. The aim of this study was to estimate the direct and indirect cost of asthma among adult patients in Italy, and to assess the relationship between healthcare resource use and asthma severity according to the Global Initiative for Asthma (GINA) classification system. A multicentre cross-sectional study was conducted in 16 Italian hospital-based specialised asthma clinics. Data collection was based on self-administered questionnaires and took place during the period May 1–November 30, 1999, and 500 consecutive patients with asthma, aged 18–55 yrs, were enrolled during regularly scheduled visits. Direct costs (drugs, physician visits, emergency service use and hospitalisation), indirect costs (loss of paid workdays) and total costs were determined in euros () for 1999. Patients with more severe disease, as classified by the GINA guideline, exhibited more night-time and daytime symptoms and were more limited in performing normal daily activities. The mean total cost of asthma per patient per year was estimated to be 1,260; drug costs accounted for 16%, physician costs 12%, emergency service and hospitalisation costs 20% and indirect costs 52% of the mean cost. Stratified by severity, the total annual cost per patient amounted to 720, 1,046, 1,535 and 3,328 for patients with intermittent, mild persistent, moderate persistent and severe persistent asthma, respectively. Asthma severity, as determined by the Global Initiative for Asthma classification, is significantly associated with symptoms, limitations in normal daily activities, asthma-related medical resource utilisation and both direct and indirect costs. Asthma control is not only a clinical but also an economic imperative. This study was supported by a grant from Merck & Co., Inc., Whitehouse Station, NJ, USA.

Although a great number of studies have been carried out on the relationship between chronic obstructive pulmonary disease (COPD) and low body weight, the identification of the most suitable warning signs of this wasting condition is still under debate. It has been indicated in earlier studies that body weight alone is of limited diagnostic value concerning this clinical condition in as far as a great number of COPD patients are usually overweight. For this reason, the aim of the current research was to find parameters that take into consideration the fact that body composition should be taken into account instead of weight only, and to assess whether COPD can be considered a "protein wasting disease", defining sensitive and significant indices of lean tissue depletion in relationship to the severity of the clinical symptoms. One hundred and seventy-five stable COPD outpatients with differing degrees of bronchial obstruction and arterial blood gas abnormalities were consecutively recruited: anthropometric measurements and body composition analysis were carried out; 60 healthy subjects with normal pulmonary function, matched for sex, age and anthropometric parameters, were considered as controls. The data obtained showed a lower prevalence (9%) of underweight COPD patients in comparison with normal weight (37%) and overweight (54%) patients. In COPD patients, the phase angle measured by bioelectrical impedance analysis, whose deterioration is a good indicator of protein mass depletion, was altered by 19%, thus allowing the identification of currently malnourished subjects included in the overweight COPD patients group. In addition, significant correlations (p = 0.000) were found between the same nutritional variable, respiratory function and gas-exchange parameters, thus confirming that the more severe the stage of the pulmonary disease, the higher the degree of protein breakdown, regardless of body weight.

Chronic airways inflammation in chronic obstructive pulmonary disease (COPD) induces the activation of several cell types with delivery of proteases and reactive oxygen species (ROS). Assessing oxidant content in the exhaled air of COPD patients has proven useful in monitoring airway inflammation. The present study was designed to confirm the usefulness of exhaled hydrogen peroxide concentration determination in COPD patients using a new technique which allows longer storage of the expired air condensate before the H2O2 assay. The technique was applied in 13 healthy nonsmoking subjects (six male, age range 22-40 yrs) and in seven patients (five male, age range 58-81 yrs) with mild or moderate COPD. Subjects breathed into a one-valve mouthpiece, and the exhaled air was directed into a vial kept at 0 degree C. After approximately 15 min of quiet breathing, 1 mL of expired air condensate was collected. An aliquot, 450 microL, of this sample was immediately added to an equal volume of a reaction mixture containing 2 mM 3,5,3',5'-tetramethylbenzidine and 40 microL of enzyme stock solution (0.5 mg.mL-1). After 15 min, 45 microL sulphuric acid was added (1 N final concentration), resulting in a reaction mixture pH of 1.0. After a further 10-min incubation, H2O2 concentration determination was performed spectrophotometrically at 450 nm. This solution, as well as the H2O2 assay, was stable foror = 24 h if the sample was kept in the dark and at 4 degrees C. There was high stability on repeated measures, with a coefficient of variation equal to zero. The mean +/- SD H2O2 level in exhaled air from normal subjects was 0.12 +/- 0.09 microM, whereas it was significantly increased in COPD patients (0.50 +/- 0.11 microM; p = 0.0001 compared to healthy subjects). In three healthy control subjects, a normal H2O2 level in expired air increased to 0.70-0.80 microM during an acute upper respiratory tract infection. This new technique of hydrogen peroxide assay in expired air condensate greatly minimizes the inaccuracy deriving from the instability of hydrogen peroxide. The preliminary results obtained using this technique provide direct evidence for increased reactive oxygen species production in the airways of stable chronic obstructive pulmonary disease patients. However, the specificity of the procedure could be reduced by the interference of upper respiratory tract infections.

Introduction and Objectives Little is known about the 24-hour profile of COPD symptoms. This study assessed the frequency/severity of 24-hour symptoms and their impact on patients’ well-being. Methods This cross-sectional, observational study was conducted in patients with stable COPD. Baseline night-time, early-morning and day-time symptoms (symptom questionnaire), dyspnoea (modified Medical Research Council dyspnoea scale [mMRC]), health status (COPD Assessment Test [CAT]), anxiety/depression levels (Hospital Anxiety and Depression Scale [HADS]) and sleep quality (COPD and Asthma Sleep Impact Scale [CASIS]) were assessed. Primary endpoint: baseline frequency, severity and inter-relationship of night-time, early-morning and day-time symptoms; secondary endpoints: relationship between 24-hour symptoms and dyspnoea, health status, anxiety/depression and sleep quality. Results 727 patients were recruited from eight countries: 65.8% male, mean ± SD age 67.2 ± 8.8 years, mean ± SD% predicted FEV 1 52.7 ± 20.6%. Early-morning/day-time symptoms were most frequent; however night-time symptoms were common (Table). Symptom severity was comparable during the night-time, early-morning and day-time. In the week prior to baseline, 56.7% patients had symptoms throughout the 24-hours (79.9% in 2 or 3 parts of the day). Breathlessness was most common (71.4% patients); its prevalence increased throughout the 24-hours (32.1% night-time, 51.6% early-morning, 65.2% day-time). Dyspnoea, health status, anxiety/depression and sleep quality were worse in patients with night-time, early-morning or day-time symptoms versus patients without symptoms in each period (all p Conclusions Most patients had COPD symptoms throughout the 24-hours. Dyspnoea, health status, anxiety/depression levels and sleep quality were significantly worse in patients who had symptoms in any part of the day.

Previous clinical therapeutic research has shown that inhaled nedocromil sodium can replace maintenance oral sustained release theophylline in the management of asthma patients.To compare directly the efficacy and safety of nedocromil sodium and sustained release theophylline.Using a randomized, double-blind, double-dummy, parallel-group design, 105 patients with reversible obstructive airways disease (77 asthmatic patients) recruited from four referred-care clinics received, in addition to their existing therapy, 4 mg nedocromil sodium four times daily or sustained release theophylline (maximum daily dose 13 mg/kg) for 6 weeks. Patients with serum theophylline levels within the therapeutic range of 10 to 20 micrograms/mL were retained for efficacy analysis. All were included in a tolerability analysis. Day and nighttime symptoms, inhaled bronchodilator use, morning tightness, cough, and twice daily peak flows were recorded on diary cards. Disease severity, lung function and unusual events were evaluated bi-weekly, and opinion of treatment after 6 weeks.Both treatments improved symptoms, inhaled bronchodilator use and lung function to the same extent. Both treatments were very to moderately effective in70% patients. The occurrence of gastrointestinal (P.05) and central nervous system (P.01) unusual events was significantly lower for nedocromil sodium compared with theophylline treated patients.Nedocromil sodium and theophylline were equally effective in this group of patients but nedocromil sodium treatment was associated with significantly fewer side effects, and therefore may be the treatment of choice.

OBJECTIVE--To investigate the relation between snoring and various respiratory symptoms and passive parental smoking. DESIGN--Data were collected by questionnaire. SETTING--Primary schools in Guardiagrele and Francavilla in the Abruzzi region in central Italy. SUBJECTS--1615 Children aged 6-13 years were categorised according to whether they snored often; occasionally apart from with colds; only with colds; or never. RESULTS--118 Children were habitual snorers and 137 were reported to snore apart from when they had colds. Never snorers (n = 822) were significantly older than children in other categories. Snoring was significantly associated with rhinitis, production of cough and sputum, previous tonsillectomy, and passive parental smoking. Of the habitual snorers, 82 were exposed to passive smoking. The prevalence of habitual snoring increased significantly with the number of cigarettes smoked by parents (from 5.5% in never smoking [corrected] households to 8.8% in heavy smoking households). CONCLUSIONS--Snoring is quite common in children. The dose-effect relation of smoking and snoring shown in this study adds weight to a further adverse effect of parental smoking on children's health.

Seventeen asthmatic, non-atopic patients (aged 15-48 years) were studied at different hours of the day. On 3 different days, they were submitted to a fog-test at 03:00 p.m. and at 03:00 a.m. On 2 different days, they were given fenoterol (200 micrograms) or Duovent (fenoterol 200 micrograms plus ipratropium bromide 80 micrograms). We were able to demonstrate significant inter-hour differences of the basal values of all parameters, except FVC, in all patients at 03:00 p.m. and at 03:00 a.m. We did not observe any inter-hour difference after the fog-test. Both fenoterol and Duovent improved challenge-induced bronchoconstriction. After the fog-test, both drugs showed an inter-hour variability of ventilatory parameters, which was not significant without drugs because it was masked by the magnitude of the obstructive response to challenge.

In six subjects with intrinsic asthma in clinical remission, time-structure of ventilatory parameters has been evaluated in order to evaluate: 1) which indexes present statistically significant circadian fluctuations; 2) if phase-shifts occur in comparison with normal subjects. After a period of synchronization of 7 days (L/D: 07.30-23.00; meal timing at 08.00, 13.00 and 20.30) all subjects have been studied by spirometry, flow-volume loop and Raw determination 6 times in a 24-hr period at constant intervals of 4 hrs. The results have been evaluated by macroscopic and microscopic analysis statistical significant fluctuations have been shown in these functional indexes: MEF50, Raw, SRaw, SGaw, FRC and RV; no phase-shifts occurred in comparison with normal subjects. On the contrary a circadian rhythm has not been shown in FVC, FEV1, and PEF. Therefore only the effort-independent test should be used to study correctly the bronchial tone.

The aim of the investigation was to demonstrate the existence of cyclic variations of bronchial tone, correlated with the increase of vagal tone during nocturnal hours and with the increase of adrenergic tone in the late morning and afternoon. Twenty-five healthy subjects were tested, utilizing forced expiration curve (V/V loop), Raw and SGaw. We did not detect a statistically significant rhythm for FVC, FEV1, PEF, because they are effort-dependent parameters. On the contrary, we demonstrated significant fluctuations for V max50, FEF25.75 (acrophase in the later morning and early afternoon), for Raw (acrophase in late evening) and for SGaw (Acrophase in antiphase with Raw); these parameters are effort-independent as well as direct and sensitive indexes of the tone of peripheral and central airways.

Background and aims. Hospitalisations for chronic obstructive pulmonary disease (COPD) exacerbations are major events in the natural history of the disease in terms of survival, quality of life and risk of further episodes of exacerbation. The aims of study were to evaluate: 1. adherence to recommended standards of care; and 2. clinical factors influencing major outcomes during hospitalisation for an episode of COPD exacerbation and within a 6-month follow-up. Methods. An observational, prospective study was conducted in 68 centres. Assessment of standards of care included diagnostic procedures (such as pulmonary function tests and microbiology) and management options (such as drug therapies, vaccinations and rehabilitation). Outcome measures relevant to the hospitalisation were: survival, need for mechanical ventilation, and length of stay (LOS). Outcomes at 6-months were: survival, exacerbations and hospitalisations for an exacerbation. Multivariate logistic regression was applied to evaluate the relation between clinical factors and outcomes. Results. 931 patients were enrolled. Only 556 patients (59.7%) were diagnosed COPD and stratified for severity with the support of spirometry (FEV1/VC ≤0.7) and were considered for outcome analysis. Among treatments, pulmonary rehabilitation and anti-smoking counselling were applied infrequently (14.5 and 8.1% of patients, respectively). Within six months 63 COPD patients (17.7%) had at least one episode of exacerbation prompting a further hospitalisation and 19 died (5.3%). Predictor of mortality was the co-morbidity Charlson index (odds ratio, OR 10.3, p=0.03 CI:1.25-84.96). A further hospitalisation was predicted by hospitalisation for an exacerbation in the previous 12 months (OR 3.59, p=0.003 CI:1.54-8.39). Conclusions. Standards of care were far lower than recommended, in particular 40% of patients were labelled as COPD without spirometry. COPD patients with a second hospitalisation in 12 months for an exacerbation had about 3 times the risk of suffering a new episode and hospitalisation in the following six months.