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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.)

Background and Aim. The Italian Costs for Exacerbations in COPD (“ICE”) study, following a pharmacoeconomic assessment of costs due to COPD exacerbations (primary endpoint), aimed also at evaluating (secondary endpoint) which clinical factors, among those considered for cost-analysis, may, at follow up, present a risk of new exacerbations and re-admission to hospital. Materials and methods. A prospective, multicentre study was carried out on COPD patients admitted to 25 Hospital Centres as a result of an exacerbation from October- December 2002. Following discharge, a 6-month follow- up was performed in each patient via three bi-monthly telephone interviews with a questionnaire administered by an investigator clinician. Results. 570 patients were eligible for data processing, mean age 70.6 years (± 9.5 standard deviation, SD), males 69.2%. According to GOLD, severity stratification was as follows: moderate 36.4%; severe 31.3%; very severe 32.3%. 282 patients experienced at least one exacerbation at follow up, 42% of exacerbations requiring hospitalisation. No significant association was seen between exacerbations and GOLD stage or co-morbidities or treatments except LTOT. Conversely, COPD functional severity influenced hospitalisations very significantly, with relative risks 2.6 (95% Confidence Interval, CI 1.8-3.8) and 2.0 (CI 1.3-2.8) (GOLD very severe versus moderate and severe, respectively), and 1.3 (CI 0.85-2.1) (GOLD severe versus moderate). Hospitalisations were also significantly associated with treatments denoting more severe conditions (oral corticosteroids, oral theophylline, and LTOT). Conclusions. Severity stratification of COPD patients according to respiratory function classes as outlined in GOLD guidelines and need for LTOT are confirmed as important predictors of hospitalisation for an exacerbation.

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.

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.

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.

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.

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.