The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS.

Background: The COVID-19 pandemic in Latin America generated the need to develop low-cost, fast-manufacturing mechanical ventilators. The Universidad de La Sabana and the Fundacion Neumologica Colombiana designed and manufactured the Unisabana-HERONS (USH) ventilator. Here, we present the preclinical and clinical study results to evaluate its effectiveness and safety characteristics in an animal model (Yorkshire Sow) and five patients with acute respiratory failure receiving mechanical ventilatory support for 24 h. Methods: The effectiveness and safety outcomes included maintaining arterial blood gases and pulse oximetry saturation (SpO2), respiratory pressures and volumes (during continuous monitoring) in the range of ARDS and lung-protective strategy goals, and the occurrence of barotrauma. A significance level of 0.05 was used for statistical tests. This clinical trial was registered on Clinicaltrials.gov (NCT04497623) and approved by the ethics committee. Results: Among patients treated with the Unisabana-HERONS, the most frequent causes of acute respiratory failure were pneumonia in 3/5 (60 %) and ARDS in 2/5 (40 %). During the treatment, the ventilatory parameters related to lung protection protocols were kept within the safety range, and vital signs and blood gas were stable. The percentage of time that the respiratory pressures or volumes were out of safety range were plateau pressure >30 cm H2O: 0.00 %; driving pressure >15 cm H2O: 0.06 %; mechanical power >15 J/min: 0.00 %; and Tidal volume >8 mL/kg: 0.00 %. There were no adverse events related to the ventilator. The usability questionnaire retrieved a median score for all items between 9 and 10 (best score: 10), indicating great ease of use. Conclusion: The Unisabana-HERONS ventilator effectively provided adequate gas exchange and maintained the ventilatory parameters in the range of lung protection strategies in humans and an animal model. Furthermore, it is straightforward to use and is a low-cost medical device.

Assessing the reproducibility and predictive value of objective cough measurement for successful withdrawal of invasive ventilatory support in adult patients.

BACKGROUND: Utilizing clinical tests, such as objective cough measurement, can assist in predicting the success of the weaning process in critically ill patients. METHODS: A multicenter observational analytical study was conducted within a prospective cohort of patients recruited to participate in COBRE-US. We assessed the capability of objective cough measurement to predict the success of the spontaneous breathing trial (SBT) and extubation. Intra- and inter-observer reproducibility of the cough test and was evaluated using the intraclass correlation coefficient (ICC) and Cohen's weighted kappa. We used receiver operating characteristic curves (ROC-curve) to evaluate the predictive ability of objective cough measurement. RESULTS: We recruited 367 subjects who were receiving invasive mechanical ventilation. A total of 451 objective cough measurements and 456 SBTs were conducted. A significant association was found between objective cough measurement and successful SBT (OR: 1.68; 95% CI 1.48-1.90; p = 0.001). The predictive capability of the objective cough test for SBT success had a ROC-curve of 0.58 (95% CI: 0.56-0.61). Objective cough measurement to predict successful extubation had a ROC-curve of 0.61 (95% CI: 0.56-0.66). The intraobserver reproducibility exhibited an ICC of 0.94 (95% CI: 0.89-0.96; p < 0.001), while the interobserver reproducibility demonstrated an ICC of 0.72 (95% CI: 0.51-0.85; p < 0.001). The intraobserver agreement, assessed using Cohen's weighted kappa was 0.94 (95% CI: 0.93-0.99; p < 0.001), whereas the interobserver agreement was 0.84 (95% CI: 0.67 - 0.10; p < 0.001). CONCLUSIONS: The objective measurement of cough using the method employed in our study demonstrates nearly perfect intra-observer reproducibility and agreement. However, its ability to predict success or failure in the weaning process is limited.

Existing and Emerging Technologies for Therapeutic Monitoring of Lithium: A Scoping Review.

BACKGROUND/PURPOSE: Lithium is an effective psychoactive drug. It has a narrow therapeutic margin, with subtherapeutic levels or intoxication commonly occurring. Therapeutic drug monitoring (TDM) of lithium has several barriers. This scoping review aims to describe and analyze existing and emerging technologies for lithium TDM and to describe the lithium quantification parameters (precision, accuracy, detection limit) attributed to each technology. METHOD: PubMed, Scopus, Web of Science, and Google Scholar were searched. Studies that described lithium quantification and complied with PRISMA-ScR guidelines were included. Articles selection was conducted by 2 researchers. Good precision was defined if its relative standard deviation <3%; acceptable, from 3% to 5%; and low, >5%. Accuracy was considered good if the error <5%; acceptable, 5%1 to 0%; and low if it was >10%. RESULTS: Of the 2008 articles found, 22 met the inclusion criteria. Of these, 14 studies concerned laboratory devices, in which precision was found to be low in one third of cases, and half had good precision. Accuracy of one third was good, another third was low, and the remaining third did not report accuracy. The other 8 studies concerned portable devices, in which precision was low in more than 60% of the cases and good in 25% of the studies. Accuracy was low in 50% of the cases, and good in just over a third. Limits of detection included the therapeutic range of lithium in all studies. CONCLUSIONS: Among emerging technologies for lithium TDM, precision and accuracy remain a challenge, particularly for portable devices.

Sputum Biomarkers in Wood and Tobacco Smoke Etiotypes of Chronic Obstructive Pulmonary Disease.

Introduction: There is a need to better understand the etiotypes of chronic obstructive pulmonary disease (COPD) beyond the tobacco-smoke (TS-COPD). Wood smoke COPD (WS-COPD) is characterized by greater airway compromise, milder emphysema, and slower rate of lung function decline than TS-COPD. However, it is unclear if these two etiotypes of COPD have differences in sputum biomarker concentrations. Objective was to compare sputum levels of selected sputum biomarkers between WS-COPD and TS-COPD, and healthy controls. Methods: Eighty-eight women (69±12 years) were recruited and classified into: WS-COPD (n=31), TS-COPD (n=29) and controls (n=28). Using ELISA, we determined induced sputum levels of metalloproteinase 9 (MMP-9), chemokine ligand 5 (CCL5), interleukin-8 (IL-8), chemokine ligand 16 (CCL16/HCC-4) and vascular endothelial growth factor (VEGF-1). Differences were analyzed by Kruskal-Wallis and Mann-Whitney-U tests and correlation between airflow limitation and biomarkers by Spearman's test. Results: At similar degree of airflow obstruction, anthropometrics and medications use, the level of sputum CCL5 was higher in TS-COPD than WS-COPD (p=0.03) without differences in MMP-9, IL-8, CCL16/HCC-4, and VEGF-1. Women with WS-COPD and TS-COPD showed significantly higher sputum levels of MMP-9, IL-8 and CCL5 compared with controls (p<0.001). FEV1% predicted correlated negatively with levels of MMP-9 (rho:-0.26; P=0.016), CCL5 (rho:-0.37; P=0.001), IL-8 (rho:-0.42; P<0.001) and VEGF (rho:-0.22; P=0.04). Conclusion: While sputum concentrations of MMP-9, IL-8, and CCL5 were higher in COPD women compared with controls, women with TS-COPD had higher levels of CCL5 compared with those with WS-COPD. Whether this finding relates to differences in pathobiological pathways remains to be determined.

Long-term survival in venous thromboembolic disease: rivaroxaban vs. warfarin - propensity score matching study.

BACKGROUND: Venous thromboembolic disease (VTE) is characterized by obstruction of venous blood flow by a thrombus. Survival data, frequency of disease recurrence, and bleeding rate in patients on anticoagulant therapy with warfarin compared to rivaroxaban in the Latin American population are limited in VTE. METHODS: A retrospective cohort study with propensity score matching analysis was conducted in patients with pulmonary embolism and/or deep vein thrombosis anticoagulated with warfarin or rivaroxaban treated. Survival analysis was performed using a Kaplan-Meier curve for each of the intervention groups, and it was compared using a Log Rank test. RESULTS: Of 2193 potentially eligible patients with a suspected diagnosis of VTE, 505 patients entered the analysis; of these, 285 subjects were managed with warfarin and 220 anticoagulated with rivaroxaban. Major bleeding at 12 months occurred in 2.7% (6/220) of patients treated with Rivaroxaban, compared to 10.2% (29/285) in the Warfarin group in the unmatched population (p = 0.001). In the matched population, bleeding at 12 months occurred in 2.9% (6/209) of patients on Rivaroxaban and in 11.0% (23/209) of patients on Warfarin (p = 0.001). The survival rates at 6 months were 97.1% for Rivaroxaban and 97.6% for Warfarin (p = 0.76). At 12 months, the survival rates were 94.7% for Rivaroxaban and 95.7% for Warfarin (p = 0.61). CONCLUSION: In the treatment of VTE, there is no differences on 6 and 12-month survival or a reduction in the occurrence of new thromboembolic events when comparing rivaroxaban to warfarin. However, a lower risk of major bleeding is observed at 12 months with Rivaroxaban.

The effect of combining different sampling tools on the performance of electromagnetic navigational bronchoscopy for the evaluation of peripheral lung lesions and factors associated with its diagnostic yield.

BACKGROUND: We assessed the performance of Electromagnetic navigational bronchoscopy (ENB) as a standalone diagnostic technique and the performance of different sampling tools used during the procedure. METHODS: We recruited 160 consecutive patients who underwent ENB for peripheral lung lesions (PLL) at a tertiary care centre. The diagnostic performance of ENB and sampling tools was assessed using a logistic regression model and a ROC-curve in which the dependent variable was diagnostic success. A multivariate model was built to predict diagnostic success before performing ENB to select the best candidates for the procedure. RESULTS: Most patients with PLLs in the study were male (65%), with a mean age of 67.9 years. The yield was 66% when the most common techniques were used together as suction catheter + transbronchial biopsy forceps (TBBx) + bronchoalveolar lavage + bronchial washing (p < 0.001) and increased to 69% when transbronchial needle aspiration (TBNA) and cytology brush were added (p < 0.001). Adding diagnostic techniques such as TBBx and TBNA resulted in an increase in diagnostic performance, with a statistically significant trend (p = 0.002). The logistic model area-under the ROC-curve for diagnostic success during ENB was 0.83 (95% CI:0.75-0.90; p < 0.001), and a logit value ≥ 0.12 was associated with ≥ 50% probability of diagnostic success. CONCLUSIONS: ENB, as a stand-alone diagnostic tool for the evaluation of PLLs when performed by experienced operators using a multi-modality technique, has a good diagnostic yield. The probability of having a diagnostic ENB could be assessed using the proposed model.

Utilization of spontaneous breathing trial, objective cough test, and diaphragmatic ultrasound results to predict extubation success: COBRE-US trial.

BACKGROUND: The results of clinical and weaning readiness tests and the spontaneous breathing trial (SBT) are used to predict the success of the weaning process and extubation. METHODS: We evaluated the capacity of the cuff leak test, rate of rapid and shallow breathing, cough intensity, and diaphragmatic contraction velocity (DCV) to predict the success of the SBT and extubation in a prospective, multicenter observational study with consecutive adult patients admitted to four intensive care units. We used receiver operating characteristic (ROC) curves to assess the tests' predictive capacity and built predictive models using logistic regression. RESULTS: We recruited 367 subjects who were receiving invasive mechanical ventilation and on whom 456 SBTs were performed, with a success rate of 76.5%. To predict the success of the SBT, we derived the following equation: (0.56 × Cough) - (0.13 × DCV) + 0.25. When the cutoff point was ≥ 0.83, the sensitivity was 91.5%, the specificity was 22.1%, and the overall accuracy was 76.2%. The area under the ROC curve (AUC-ROC) was 0.63. To predict extubation success, we derived the following equation: (5.7 × SBT) + (0.75 × Cough) - (0.25 × DCV) - 4.5. When the cutoff point was ≥ 1.25, the sensitivity was 96.8%, the specificity was 78.4%, and the overall accuracy was 91.5%. The AUC-ROC of this model was 0.91. CONCLUSION: Objective measurement of cough and diaphragmatic contraction velocity could be used to predict SBT success. The equation for predicting successful extubation, which includes SBT, cough, and diaphragmatic contraction velocity values, showed excellent discriminative capacity.

The Challenges of Spirometric Diagnosis of COPD.

Chronic obstructive pulmonary disease (COPD) is one of the top causes of morbidity and mortality worldwide. Although for many years its accurate diagnosis has been a focus of intense research, it is still challenging. Due to its simplicity, portability, and low cost, spirometry has been established as the main tool to detect this condition, but its flawed performance makes it an imperfect COPD diagnosis gold standard. This review aims to provide an up-to-date literature overview of recent studies regarding COPD diagnosis; we seek to identify their limitations and establish perspectives for spirometric diagnosis of COPD in the XXI century by combining deep clinical knowledge of the disease with advanced computer analysis techniques.

Risk factors for persistent tomographic abnormalities at 6 months of follow-up in a cohort of hospitalized patients with moderate and severe COVID-19 living at high altitude.

Introduction: After COVID-19, functional and tomographic lung alterations may occur, but there are no studies at high altitude where, due to lower barometric pressure, there are lower levels of arterial oxygen pressure and saturation in both normal subjects and patients with respiratory disease. In this study, we evaluated the computed tomographic (CT), clinical, and functional involvement at 3 and 6 months post-hospitalization in survivors with moderate-severe COVID-19, as well the risk factors associated with abnormal lung computed tomography (ALCT) at 6 months of follow-up. Materials and methods: Prospective cohort, after hospitalization for COVID-19, of patients older than 18 years residing at high altitude. Follow-up at 3 and 6 months with lung CT, spirometry, diffusing capacity of the lung for carbon monoxide (DLCO), six-minute walk test (6MWT), and oxygen saturation (SpO2). Comparisons between ALCT and normal lung computed tomography (NLCT) groups with X2 and Mann-Whitney U test, and paired test for changes between 3 and 6 months. A multivariate analysis was performed to evaluate the variables associated with ALCT at 6-month follow-up. Results: We included 158 patients, 22.2% hospitalized in intensive care unit (ICU), 92.4% with typical COVID CT scan (peripheral, bilateral, or multifocal ground glass, with or without consolidation or findings of organizing pneumonia), and median hospitalization of 7 days. At 6 months, 53 patients (33.5%) had ALCT. There were no differences between ALCT and NLCT groups in symptoms or comorbidities on admission. ALCT patients were older and more frequently men, smokers and hospitalized in ICU. At 3 months, ALCT patients had more frequently a reduced forced vital capacity (< 80%), and lower meters walked (6MWT) and SpO2. At 6 months, all patients improved lung function with no differences between groups, but there were more dyspnea and lower exercise SpO2 in ALCT group. The variables associated with ALCT at 6 months were age, sex, ICU stay, and typical CT scan. Conclusion: At 6-month follow-up, 33.5% of patients with moderate and severe COVID had ALCT. These patients had more dyspnea and lower SpO2 in exercise. Regardless of the persistence of tomographic abnormalities, lung function and 6MWT improved. We identified the variables associated with ALCT.

Association between erectile dysfunction and the severity of obstruction to airflow in patients with chronic obstructive pulmonary disease / Asociación entre disfunción eréctil y la severidad de la obstrucción al flujo aéreo en pacientes con enfermedad pulmonar obstructiva crónica

Objectives: The objective of this study was to explore a possible association between ED and the severity of airflow obstruction in patients with COPD. Materials and methods: A cross-sectional study was conducted using the International Index Erectile Function (IIEF), a scale validated and translated to Spanish. Bivariate analyses between subgroups were made for quantitative variables using a t-test for means and Mann­Whitney U for medians; qualitative variables were compared using the χ2 test or Fisher's test, depending on distribution. Confusion bias in the association between ED and airflow obstruction was controlled using a logistic regression model. Results: The Spanish version of the IIEF-15 scale was valid and applicable to the Colombian population. The prevalence of ED in COPD patients living at high altitudes was similar to that found at sea level. Such prevalence is higher than in general population. Beta-blockers increased 7 times the risk of ED, but we found no association between the degree of airflow obstruction and ED. Conclusion: Although the severity of COPD is not associated with ED, the prevalence of ED in COPD is higher than in general population. Therefore, ED screening in COPD patients using the IIEF could be justified. The strong association between beta-blockers and ED had not been previously described in patients with COPD but must be considered in their clinical management.

Objetivos: Explorar una posible asociación entre DE y severidad de la obstrucción al flujo aéreo en pacientes con EPOC. Materiales y métodos: Estudio de corte transversal aplicando el Índice Internacional de Función Eréctil (IIFE), validado y traducido al español. Se realizó análisis bivariado para variables cuantitativas usando prueba-t para medias y U de Mann Whitney para medianas; las variables cualitativas fueron comparadas usando prueba de Chi2 o test de Fisher, según distribución. Los sesgos de confusión en la asociación entre DE y obstrucción al flujo aéreo fueron controlados usando un modelo de regresión logística. Resultados: La versión en español de la escala IIFE-15 fue aplicable en población colombiana. La prevalencia de DE en pacientes con EPOC viviendo a gran altura fue similar a lo encontrado a nivel del mar. Esta prevalencia es mayor que en población general. El uso de beta-bloqueadores aumentó hasta siete veces el riesgo de DE, pero no se encontró asociación entre el grado de obstrucción y la DE. Conclusiones: Aunque la severidad de la EPOC no está asociada con DE, la prevalencia de DE en EPOC es mayor que en población general. Está justificada la realización de tamizaje usando el IIFE. La asociación fuerte entre beta-bloqueadores y DE no se ha descrito previamente en pacientes con EPOC, pero debe considerarse en su manejo.

Learning curves and association of pathologist's performance with the diagnostic accuracy of linear endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA): a cohort study in a tertiary care reference centre.

OBJECTIVES: We aimed to assess the learning curves and the influence of the pathologist's performance on the endobronchial ultrasound transbronchial needle aspiration's (EBUS-TBNA's) diagnostic accuracy in a real-world study. DESIGN/SETTING: Cohort study conducted in a tertiary care university hospital (single centre) with patients referred for EBUS-TBNA. PARTICIPANTS/INTERVENTION: We initially evaluated 376 patients (673 lymph nodes), 368 (660 lymph nodes) of whom were recruited. The inclusion criterion was EBUS-TBNA indicated for the study of mediastinal or hilar lesions. The exclusion criteria were the absence of mediastinal and hilar lesions during EBUS confirmed by a normal mediastinum and hilum on chest CT (except in cases of mediastinal staging of cancer) and lost to follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: Diagnostic accuracy and related outcomes. METHODS: We included patients from a prospectively constructed database. We performed a logistic regression multivariate analysis to adjust for potential confounders of the association between pathologist performance and EBUS-TBNA accuracy. The Cumulative Summation (CUSUM) analysis was used to assess pathologists' performance and learning curves. RESULTS: Most indications for EBUS were suspicion of malignancy, including intrathoracic tumours (68.3%), extrathoracic tumours (9.8%) and cancer staging (7.0%). The patients' mean age was 63.7 years, and 71.5% were male. Overall EBUS-TBNA accuracy was 80.8%. In the multivariate logistic regression model, the factors independently associated with EBUS-TBNA accuracy included certain pathologists (ORs ranging from 0.16 to 0.41; p<0.017), a lymph node short-axis diameter <1 cm (OR: 0.36; 95% CI 0.21 to 0.62; p<0.001), and the aetiology of lymph node enlargement (ORs ranging from 7 to 37; p<0.001). CUSUM analysis revealed four different learning curve patterns, ranging from almost immediate learning to a prolonged learning phase, as well as a pattern consistent with performance attrition. CONCLUSIONS: Pathologists' proficiency conditioned EBUS-TBNA accuracy. This human factor is a potential source of error independent of factors conditioning tissue sample adequacy.

Simple and Autonomous Sleep Signal Processing System for the Detection of Obstructive Sleep Apneas.

Obstructive sleep apnea (OSA) is a common sleep disorder characterized by repetitive upper airway obstruction, intermittent hypoxemia, and recurrent awakenings during sleep. The most used treatment for this syndrome is a device that generates a positive airway pressure­Continuous Positive Airway Pressure (CPAP), but it works continuously, whether or not there is apnea. An alternative consists on systems that detect apnea episodes and produce a stimulus that eliminates them. Article focuses on the development of a simple and autonomous processing system for the detection of obstructive sleep apneas, using polysomnography (PSG) signals: electroencephalography (EEG), electromyography (EMG), respiratory effort (RE), respiratory flow (RF), and oxygen saturation (SO2). The system is evaluated using, as a gold standard, 20 PSG tests labeled by sleep experts and it performs two analyses. A first analysis detects awake/sleep stages and is based on the accumulated amplitude in a channel-dependent frequency range, according to the criteria of the American Academy of Sleep Medicine (AASM). The second analysis detects hypopneas and apneas, based on analysis of the breathing cycle and oxygen saturation. The results show a good estimation of sleep events, where for 75% of the cases of patients analyzed it is possible to determine the awake/asleep states with an effectiveness of >92% and apneas and hypopneas with an effectiveness of >55%, through a simple processing system that could be implemented in an electronic device to be used in possible OSA treatments.

Pneumonia, Mortality, and Other Outcomes Associated with Unsafe Swallowing Detected via Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in Patients with Functional Oropharyngeal Dysphagia: A Systematic Review and Meta-analysis.

The association between impairments in swallowing safety detected via fiberoptic endoscopic evaluation of swallowing (FEES) and dysphagia complications has been evaluated in small studies that have not allowed obtaining precise estimates of the presence of such an association. The objective of this study was to evaluate the risk of dysphagia complications associated with the detection of premature spillage, residue, penetration, and aspiration via FEES. A systematic review and meta-analysis of the literature were carried out. A search strategy was established using terms of controlled and free vocabulary (free text) in the PubMed, Lilacs, Embase, Medline, and Cochrane databases. The initial search in the databases identified 3545 articles, of which 321 were excluded due to duplication, 3224 were selected for review of titles and abstracts, 45 were selected for full-text review, 37 were excluded for not meeting the selection criteria, and 8 were included for the final analysis, with a total population of 1168 patients. Aspiration increased the risk of pneumonia (OR 2.97, 95% CI 1.52-5.80, P = 0.001). The number of studies that have evaluated the relationship of other FEES findings with dysphagia complications was limited (≤ 3). One study found a higher risk of mortality in patients with aspiration (OR 4.08, 95% CI 1.60-10.27, P = 0.003). Another study that evaluated the risk of mortality in a combined group of penetration and aspiration found no higher risk of mortality. Penetration, residue, and premature spillage were not found to be associated with an increased risk of pneumonia, mortality, or other outcomes. Aspiration demonstrated via FEES was associated with an increased risk of pneumonia and mortality. There is insufficient evidence for the capacity of premature spillage, penetration, and residue to predict dysphagia complications.

BASAN index (Body mass index, Age, Sex, Arterial hypertension and Neck circumference) predicts severe apnoea in adults living at high altitude.

OBJECTIVES: Obstructive sleep apnoea (OSA)/hypopnoea syndrome is associated with serious and major multiorgan morbidities, particularly in its most severe forms. However, no severe OSA screening instruments are available for high altitude residents that enable adequate identification and clinical prioritisation of such patients. We aimed at developing a severe OSA prediction tool based on the clinical characteristics and anthropometric measurements of a clinical referral cohort living at 2640 m.a.s.l. DESIGN: Cohort-nested cross-sectional study. SETTING: Sleep laboratory for standard polysomnography (PSG) in Colombia. PARTICIPANTS: A predictive model was generated from 8718 participants referred to the PSG laboratory. Results were subsequently validated in a second cohort of 1898 participants. PRIMARY OUTCOME: To identify clinical and anthropometric variables associated with severe OSA (>30 events/hour) and to include them in a binary logistic regression model. RESULTS: The significant variables that were retained with the presence of severe OSA included Body mass index (BMI), Age, Sex, Arterial hypertension and Neck circumference (BASAN). The area under the receiver operating characteristic curvefor the BASAN index was 0.69 (95% CI: 0.68 to 0.70) in the derivation cohort and 0.67 (95% CI: 0.65 to 0.69) in the validation cohort, whereby a BASAN index ≥2 had a sensitivity of 95% and a specificity of 17% to detect severe OSA. CONCLUSION: An objectively based approach to screen for the presence of severe OSA, the BASAN index, exhibits favourable sensitivity characteristics that should enable its operational use as a screening tool in a Hispanic population with a clinical suspicion of OSA and living at high altitude.

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services.

BACKGROUND: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist's perception of its quality has not been evaluated. METHODS: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of central tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. RESULTS: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfied in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores > 70/100 from the first procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score. CONCLUSIONS: The aScope4™ scored well for ease of use, imaging, and aspiration. We found a learning curve with excellent scores from the 9th procedure. Bronchoscopists highlighted its portability, immediacy of use and the possibility of taking and storing images.

Cost-utility analysis of an integrated care program for children with asthma in a medium-income country.

OBJECTIVE: To evaluate the cost-utility of an integrated care program (ASMAIRE Infantil Program [PAI]) for children with asthma compared with standard of care. METHODS: A decision-analytic model was used to compare an integrated care program compared to the standard of care in children with asthma in Bogota, Colombia. Baseline characteristics of the patients were established according to the distribution of patients in the PAI database. Other inputs were obtained from published meta-analysis, local registries, medical bills, general mortality data, and expert opinion. Costs were presented in 2017 Colombian pesos. Outcomes included quality-adjusted life-years (QALYs). Costs and outcomes were discounted by 5% per year. Incremental cost-utility ratios were presented for PAI compared with standard of care. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness to parameter uncertainty. RESULTS: The model predicted that patients that are part of the PAI would accrue more QALYs than patients on standard of care. The incremental results suggest that the PAI is a cost-effective treatment (incremental cost-utility ratio of Colombian pesos $33 753 817/QALY) compared with standard of care. Sensitivity analyses suggest that results are most sensitive to cost of care (with and without PAI) and costs of severe exacerbation. However, the PAI is cost-effective irrespective of variation in any of the input parameters. CONCLUSION: Our model predicted that an integrated intervention for the management of asthma in pediatric patients improves QALYs, reduces number of disease related exacerbations compared to standard therapy and is cost-effective for the long-term control of the disease in Colombia.

Aspiration in the Fiberoptic Endoscopic Evaluation of Swallowing Associated with an Increased Risk of Mortality in a Cohort of Patients Suspected of Oropharyngeal Dysphagia.

There is a general lack of published studies on the risk of mortality due to alterations in the safety of swallowing detected during the fiberoptic endoscopic evaluation of swallowing (FEES). We aimed at assessing the risk of mortality of the detection of aspiration, penetration, and pharyngeal residues by FEES. A cohort of consecutively evaluated patients suspected of experiencing oropharyngeal dysphagia undergoing FEES at a tertiary care university hospital were prospectively followed up on to assess mortality. The FEES findings, comorbidities, and potential confounders were studied as predictors of death using a Cox multivariate regression analysis. A total of 148 patients were included, 85 of whom were male (57.4%). The mean age (± standard deviation) was 52.7 years (± 22.1). The median of the follow-up time was 4.5 years. The most frequent conditions were stroke in 50 patients (33.8%), brain and spine traumas in 27 (18.2%), and neurodegenerative diseases in 19 (12.8%). Variables associated with mortality in bivariate analyses were age > 65 years (p < 0.001), pneumonia (p = 0.046), aspiration of any consistency (p < 0.001), and pharyngeal residues (p = 0.017). Variables independently associated with mortality in the Cox multivariate model were age (> 65 years) [adjusted hazard ratio (HR) 5.76; 95% CI 2.72 to 17.19; p = 0.001] and aspiration (adjusted HR: 3.96; 95% CI 1.82 to 14.64; p = 0.003). Aspiration detected by FEES and an age > 65 years are independent predictors of mortality in patients with oropharyngeal dysphagia.

Allergic Rhinitis and OSA in Children Residing at a High Altitude.

BACKGROUND: OSA affects 2% to 4 % of the pediatric population; allergic rhinitis (AR) has been identified as a risk factor in sleep-disordered breathing, but no studies evaluating such an association have been conducted in high-altitude environments. The goal of this study was to assess whether the severity of AR is associated with the severity of OSA in children undergoing polysomnography (PSG) in the high-altitude city of Bogotá, Colombia. METHODS: A cross-sectional observational study of children with AR was conducted. Severity of AR was evaluated by using the AR health-related quality of life questionnaire for children (ESPRINT-15) and the Allergic Rhinitis and its Impact on Asthma (ARIA) classification. Diagnosis and severity of OSA were established by using PSG. Potential associations between AR severity and OSA severity were assessed by using binary logistic regression and the Spearman correlation coefficient (ρ). RESULTS: A total of 99 children (mean age, 7.9 years; 45% female) were included; 53% had OSA. An ESPRINT-15 score was associated with severe OSA (OR, 2.0; 95% CI, 1.12-6.04; P = .01). Patients with moderate/severe persistent rhinitis according to ARIA exhibited a 10.1-fold greater risk of severe OSA (OR, 10.15; 95% CI, 1.15-89.0). Furthermore, the apnea-hypopnea index was associated with the ESPRINT-15 score (ρ = 0.215; P = .03) and with the ARIA severity scale (P = .04; ρ = 0.203). CONCLUSIONS: In symptomatic children with AR residing at a high altitude, increasing AR severity is associated with more severe OSA.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

INTRODUCTION: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. OBJECTIVE: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. MATERIALS AND METHODS: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. RESULTS: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). CONCLUSIONS: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

Introduction: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. Objective: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. Materials and methods: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. Results: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). Conclusions: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.