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1.
Thorax ; 78(4): 354-361, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-35580898

RESUMEN

RATIONALE: In patients with COVID-19 pneumonia and mild hypoxaemia, the clinical benefit of high-flow nasal oxygen (HFNO) remains unclear. We aimed to examine whether HFNO compared with conventional oxygen therapy (COT) could prevent escalation of respiratory support in this patient population. METHODS: In this multicentre, randomised, parallel-group, open-label trial, patients with COVID-19 pneumonia and peripheral oxygen saturation (SpO2) ≤92% who required oxygen therapy were randomised to HFNO or COT. The primary outcome was the rate of escalation of respiratory support (ie, continuous positive airway pressure, non-invasive ventilation or invasive mechanical ventilation) within 28 days. Among secondary outcomes, clinical recovery was defined as the improvement in oxygenation (SpO2 ≥96% with fractional inspired oxygen (FiO2) ≤30% or partial pressure of arterial carbon dioxide/FiO2 ratio >300 mm Hg). RESULTS: Among 364 randomised patients, 55 (30.3%) of 181 patients assigned to HFNO and 70 (38.6%) of 181 patients assigned to COT underwent escalation of respiratory support, with no significant difference between groups (absolute risk difference -8.2% (95% CI -18% to +1.4%); RR 0.79 (95% CI 0.59 to 1.05); p=0.09). There was no significant difference in clinical recovery (69.1% vs 60.8%; absolute risk difference 8.2% (95% CI -1.5% to +18.0%), RR 1.14 (95% CI 0.98 to 1.32)), intensive care unit admission (7.7% vs 11.0%, absolute risk difference -3.3% (95% CI -9.3% to +2.6%)), and in hospital length of stay (11 (IQR 8-17) vs 11 (IQR 7-20) days, absolute risk difference -1.0% (95% CI -3.1% to +1.1%)). CONCLUSIONS: Among patients with COVID-19 pneumonia and mild hypoxaemia, the use of HFNO did not significantly reduce the likelihood of escalation of respiratory support. TRIAL REGISTRATION NUMBER: NCT04655638.


Asunto(s)
COVID-19 , Humanos , COVID-19/complicaciones , COVID-19/terapia , Oxígeno , Terapia por Inhalación de Oxígeno , Hipoxia/etiología , Hipoxia/terapia , Respiración Artificial
2.
Eur Respir J ; 61(4)2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36356972

RESUMEN

BACKGROUND: Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking. METHODS: We conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering versus dexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction (P aO2 /F IO2 ) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14. RESULTS: 677 randomised patients were included. Findings are reported as methylprednisolone (n=337) versus dexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%) versus 41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14) versus 24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%) versus 45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%) versus 9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11) versus 14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not in P aO2 /F IO2 ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points. CONCLUSION: Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID-19 pneumonia.


Asunto(s)
COVID-19 , Adulto , Humanos , Metilprednisolona , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19 , Dexametasona , Oxígeno , Resultado del Tratamiento
3.
Acta Anaesthesiol Scand ; 67(5): 569-575, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36691710

RESUMEN

This rapid practice guideline provides evidence-based recommendations for the use of awake proning in adult patients with acute hypoxemic respiratory failure due to COVID-19. The panel included 20 experts from 12 countries, including one patient representative, and used a strict conflict of interest policy for potential financial and intellectual conflicts of interest. Methodological support was provided by the guidelines in intensive care, development, and evaluation (GUIDE) group. Based on an updated systematic review, and the grading of recommendations, assessment, development, and evaluation (GRADE) method we evaluated the certainty of evidence and developed recommendations using the Evidence-to-Decision framework. We conducted an electronic vote, requiring >80% agreement amongst the panel for a recommendation to be adopted. The panel made a strong recommendation for a trial of awake proning in adult patients with COVID-19 related hypoxemic acute respiratory failure who are not invasively ventilated. Awake proning appears to reduce the risk of tracheal intubation, although it may not reduce mortality. The panel judged that most patients would want a trial of awake proning, although this may not be feasible in some patients and some patients may not tolerate it. However, given the high risk of clinical deterioration amongst these patients, awake proning should be conducted in an area where patients can be monitored by staff experienced in rapidly detecting and managing clinical deterioration. This RPG panel recommends a trial of awake prone positioning in patients with acute hypoxemic respiratory failure due to COVID-19.


Asunto(s)
COVID-19 , Deterioro Clínico , Insuficiencia Respiratoria , Adulto , Humanos , COVID-19/complicaciones , COVID-19/terapia , Posición Prona , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/terapia , SARS-CoV-2 , Vigilia
4.
Eur Respir J ; 59(4)2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34649974

RESUMEN

BACKGROUND: High-flow nasal cannula (HFNC) has become a frequently used noninvasive form of respiratory support in acute settings; however, evidence supporting its use has only recently emerged. These guidelines provide evidence-based recommendations for the use of HFNC alongside other noninvasive forms of respiratory support in adults with acute respiratory failure (ARF). MATERIALS AND METHODOLOGY: The European Respiratory Society task force panel included expert clinicians and methodologists in pulmonology and intensive care medicine. The task force used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methods to summarise evidence and develop clinical recommendations for the use of HFNC alongside conventional oxygen therapy (COT) and noninvasive ventilation (NIV) for the management of adults in acute settings with ARF. RESULTS: The task force developed eight conditional recommendations, suggesting the use of 1) HFNC over COT in hypoxaemic ARF; 2) HFNC over NIV in hypoxaemic ARF; 3) HFNC over COT during breaks from NIV; 4) either HFNC or COT in post-operative patients at low risk of pulmonary complications; 5) either HFNC or NIV in post-operative patients at high risk of pulmonary complications; 6) HFNC over COT in nonsurgical patients at low risk of extubation failure; 7) NIV over HFNC for patients at high risk of extubation failure unless there are relative or absolute contraindications to NIV; and 8) trialling NIV prior to use of HFNC in patients with COPD and hypercapnic ARF. CONCLUSIONS: HFNC is a valuable intervention in adults with ARF. These conditional recommendations can assist clinicians in choosing the most appropriate form of noninvasive respiratory support to provide to patients in different acute settings.


Asunto(s)
Ventilación no Invasiva , Síndrome de Dificultad Respiratoria , Insuficiencia Respiratoria , Adulto , Cánula , Humanos , Ventilación no Invasiva/métodos , Oxígeno , Terapia por Inhalación de Oxígeno/métodos , Síndrome de Dificultad Respiratoria/terapia , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/terapia
5.
Eur Respir J ; 60(4)2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35361632

RESUMEN

RATIONALE: Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. METHODS: In this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. RESULTS: Overall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0-17.0 days and 16 days, 95% CI 13.8-18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71-1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0% versus 16.1%; HR 1.26, 95% CI 0.74-2.16; p=0.176) or overall mortality (10.0% versus 12.2%; HR 0.83, 95% CI 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. CONCLUSIONS: Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.


Asunto(s)
Tratamiento Farmacológico de COVID-19 , Humanos , SARS-CoV-2 , Metilprednisolona , Glucocorticoides , Método Doble Ciego , Oxígeno , Resultado del Tratamiento
6.
Respiration ; 101(7): 654-657, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35367988

RESUMEN

BACKGROUND: The Severe Respiratory Insufficiency Questionnaire (SRI) is a multidimensional instrument for health-related quality of life (HRQL) assessment in patients with chronic respiratory failure (CRF). The SRI has originally been developed in German in 2003, but 15 translated versions have been created during the last 18 years with the exclusion of the Italian translation. AIMS OF THE STUDY: The present project was aimed at creating an Italian version of the SRI. METHODS: Professional forward-translation and back-translation procedures have been provided based on the original German version by independent translators, and this was followed by final reconciliation. RESULTS: The Italian SRI contains 49 items covering 7 different subscales which can summarize to one Summary Score. CONCLUSIONS: The Italian SRI is a multidimensional instrument, which can be used for HRQL assessment in Italian-speaking patients with CRF. Validation of the Italian version of the questionnaire is formally required in the future.


Asunto(s)
Insuficiencia Respiratoria , Encuestas y Cuestionarios , Humanos , Gravedad del Paciente , Calidad de Vida , Reproducibilidad de los Resultados , Insuficiencia Respiratoria/diagnóstico , Traducciones
7.
Int J Clin Pract ; 2022: 3368077, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35814307

RESUMEN

Propofol-based sedation provides faster recovery than midazolam-based regimens with similar safety and comfort during video flexible bronchoscope (VFB) procedures. Pulmonologist-administered propofol "balanced" analgosedation (PAP-BAS) is still debated in Italy. In this real-life study, PAP-BAS safety and comfort during VFB procedures were investigated. We analysed prospectively the subjects undergoing elective VFB procedures in the Pulmonology and RICU of Arezzo Hospital between February and July 2019. PAP-BAS combined low propofol and meperidine doses titrated to achieve an RASS score between 0 and -3. The primary end-point was the complications' rate. Secondary end-points were as follows: the relation between propofol's dose and a subject's comfort assessed with a VAS, recovery time according to a modified Aldrete score ≥9, RASS, and subjects' will of undergoing the procedure again. We collected postprocedure symptoms' intensity too. Our 158 study patients (67 years; SD ± 14; 64% males) incurred in 25% of complication, fully resolved with medical therapy. Neither recourse to ventilator support nor death was reported. Intraprocedural comfort was good (94% of VAS score ≤2). Among postprocedural symptoms, cough was the most frequently reported, in 36% of the cases. Although half of subjects remembered the procedure, 90% of them would have repeated it, if necessary. 85% of them recovered from procedures within 10 minutes. Complications, VAS, and recovery time were not correlated with propofol dose. To our knowledge, this is the first Italian study showing that PAP-BAS to perform a VFB procedure is safe, well tolerated with a quick recovery. Randomised controlled trials are warranted to confirm these preliminary results.


Asunto(s)
Propofol , Sedación Consciente/métodos , Femenino , Humanos , Hipnóticos y Sedantes , Masculino , Meperidina , Midazolam/efectos adversos , Propofol/efectos adversos , Neumólogos
8.
Monaldi Arch Chest Dis ; 93(4)2022 Nov 29.
Artículo en Inglés | MEDLINE | ID: mdl-36445246

RESUMEN

Long-term home noninvasive ventilation (LTHNIV) in restrictive thoracic diseases was explored via the recently published international REINVENT ERS survey. The Italian subset of respondents (ITA-r), the highest above all participating nations, was analyzed and compared to non-Italian respondents (NO-ITA-r). The ITA-r represented 20% of the total answers examined. Ninety-four percent were physicians, whose half worked in a respiratory ICU (RICU). ITA-r mainly worked in community hospitals vs NO-ITA-r who are largely affiliated with university hospitals (p<0.0001). Amyotrophic lateral sclerosis (ALS) was considered the most common medical condition leading to NIV indication by both ITA-r and NO-ITA-r (93% vs 78%, p>0.5). A greater proportion of ITA-r considered MIP/MEP the most important test for NIV initiation as compared to NO-ITA-r (p<0.05). There was no significant difference for both ITA-r and NO-ITA-r as regards the other questions. This study illustrates Italian LTHNIV practices in patients with NMD and it shows some important differences with the other countries' practices but agreement in terms of goals to achieve, reasons to initiate NIV, and practices among the two communities.


Asunto(s)
Esclerosis Amiotrófica Lateral , Ventilación no Invasiva , Insuficiencia Respiratoria , Humanos , Respiración Artificial , Italia , Encuestas y Cuestionarios , Insuficiencia Respiratoria/terapia
9.
Pulm Pharmacol Ther ; 71: 102076, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34530132

RESUMEN

BACKGROUND: Given COPD heterogeneity, we do not know if some LABA/LAMAs are more suitable for some COPD phenotypes. This real-life database study aimed to evaluate retrospectively the 4 LABA/LAMA effectiveness and highlight possible specificities that could better guide us in choosing the right LABA/LAMA to be used. METHODS: We searched for subjects (1,779) adherent to umeclidinium/vilanterol (UM/VI), indacaterol/glycopyrronium (IND/GLY), aclidinium/formoterol (ACLI/FOR) and tiotropium/olodaterol (TIO/OLO) treatments in our prescribing/dispensing database. Prescriptions for systemic corticosteroids (SC), antibiotics and salbutamol during one year of LABA/LAMA treatment were analyzed. RESULTS: A better adherence was found in individuals taking IND/GLY (10.42 ± 1.86 packages/year) compared with UM/VI (10.09 ± 1.9; p = 0.008), ACLI/FOR (9.8 ± 1.8; p = 0.001) and TIO/OLO (10.1 ± 2.1; p = 0.047). The number of patients that were prescribed at least one package of SC/year and their package numbers/year were similar in males/females, across age groups and in "non-frequent exacerbators" with the 4 LABA/LAMAs. More SC were taken by frequent exacerbators, whereas fewer SC/antibiotic packages were prescribed to subjects aged >80 years with all treatments. In patients treated with ACLI/FOR or TIO/OLO, lower risks to having antibiotic prescriptions were observed when UM/VI (0.698[0.516-0.945] and 0.696[0.491-0.985; p = 0.020 and p = 0.041) and IND/GLY (0.597[0.445-0.802] and 0.595[0.423-0.836]; p = 0.001 and p = 0.003) were considered as landmarks. Lower risks for salbutamol prescriptions were detected with UM/VI (0.678[0.480-0.958]; p = 0.027) and TIO/OLO (0.585[0.365-0.937]; p = 0.026) when ACLI/FOR was used as a reference. CONCLUSION: According to our retrospective database study, each LABA/LAMA could have a specific efficacy profile in COPD that might be considered for personalized therapy. However, head-to-head targeted trials aimed to assess the impact of different LABA/LAMAs on COPD are needed to confirm/disprove such results.


Asunto(s)
Agonistas de Receptores Adrenérgicos beta 2 , Enfermedad Pulmonar Obstructiva Crónica , Administración por Inhalación , Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Broncodilatadores/uso terapéutico , Combinación de Medicamentos , Femenino , Glicopirrolato/uso terapéutico , Humanos , Masculino , Antagonistas Muscarínicos/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Estudios Retrospectivos , Resultado del Tratamiento
10.
BMC Infect Dis ; 21(1): 433, 2021 May 08.
Artículo en Inglés | MEDLINE | ID: mdl-33964874

RESUMEN

BACKGROUND: Primary endobronchial actinomycosis is exceptionally uncommon and can be misdiagnosed as unresolving pneumonia, endobronchial lipoma, bronchogenic carcinoma or foreign body. Predisposing factors are immunosuppressive conditions, chronic lung diseases, poor oral hygiene or foreign body aspiration. CASE PRESENTATION: We reported a case of 88-year old woman with a 4 days history of mild exertional dyspnea, productive cough with purulent sputum and fever up to 37.8 °C, who developed left sided endobronchial actinomycosis in absence of any pre-existent risk conditions; endobronchial de-obstruction and specific antibiotic treatment were performed with success, achieving a full resolution of the disease, with bronchoscopy playing a key role in the diagnosticand therapeutic pathways. CONCLUSIONS: This case raises the necessity for increased awareness in the management of endobronchial lesions and in cases of suspected endobronchial actinomycosis; bronchoscopy plays a key role in the diagnostic and therapeutic process; prompt recognition of this entity can expedite proper treatment and recovery.


Asunto(s)
Actinomicosis/complicaciones , Actinomicosis/tratamiento farmacológico , Atelectasia Pulmonar/diagnóstico , Atelectasia Pulmonar/etiología , Actinomicosis/diagnóstico , Anciano de 80 o más Años , Antibacterianos/uso terapéutico , Biopsia , Enfermedades Bronquiales/complicaciones , Enfermedades Bronquiales/diagnóstico , Enfermedades Bronquiales/tratamiento farmacológico , Broncoscopía/métodos , Tos/etiología , Femenino , Fiebre/etiología , Humanos , Atelectasia Pulmonar/tratamiento farmacológico
11.
Respiration ; 100(10): 1027-1037, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34102641

RESUMEN

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.


Asunto(s)
COVID-19/terapia , Cuidados Críticos/organización & administración , Unidades de Cuidados Intensivos/organización & administración , Instituciones de Cuidados Intermedios/organización & administración , Insuficiencia Respiratoria/terapia , Terapia Respiratoria , Adulto , COVID-19/complicaciones , Hospitalización , Humanos , Italia , Selección de Paciente , Insuficiencia Respiratoria/etiología , Sociedades Médicas
12.
Eur Respir J ; 56(5)2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32747398

RESUMEN

INTRODUCTION: The severe acute respiratory syndrome-coronavirus 2 outbreak spread rapidly in Italy and the lack of intensive care unit (ICU) beds soon became evident, forcing the application of noninvasive respiratory support (NRS) outside the ICU, raising concerns over staff contamination. We aimed to analyse the safety of the hospital staff and the feasibility and outcomes of NRS applied to patients outside the ICU. METHODS: In this observational study, data from 670 consecutive patients with confirmed coronavirus disease 2019 referred to pulmonology units in nine hospitals between March 1 and May 10, 2020 were analysed. Data collected included medication, mode and usage of NRS (i.e. high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), noninvasive ventilation (NIV)), length of stay in hospital, endotracheal intubation (ETI) and deaths. RESULTS: 42 (11.1%) healthcare workers tested positive for infection, but only three of them required hospitalisation. Data are reported for all patients (69.3% male), whose mean±sd age was 68±13 years. The arterial oxygen tension/inspiratory oxygen fraction ratio at baseline was 152±79, and the majority (49.3%) of patients were treated with CPAP. The overall unadjusted 30-day mortality rate was 26.9%, with 16%, 30% and 30% for HFNC, CPAP and NIV, respectively, while the total ETI rate was 27%, with 29%, 25% and 28%, respectively; the relative probability of death was not related to the NRS used after adjustment for confounders. ETI and length of stay were not different among the groups. Mortality rate increased with age and comorbidity class progression. CONCLUSIONS: The application of NRS outside the ICU is feasible and associated with favourable outcomes. Nonetheless, it was associated with a risk of staff contamination.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/terapia , Cuidados Críticos , Ventilación no Invasiva , Neumonía Viral/complicaciones , Neumonía Viral/terapia , Anciano , Anciano de 80 o más Años , COVID-19 , Estudios de Cohortes , Infecciones por Coronavirus/mortalidad , Estudios de Factibilidad , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/mortalidad , SARS-CoV-2
13.
Crit Care ; 24(1): 692, 2020 12 14.
Artículo en Inglés | MEDLINE | ID: mdl-33317579

RESUMEN

BACKGROUND: The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. METHODS: We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25-7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. RESULTS: Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were - 6.8 mmHg (± 8.7) in the HFNT and - 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. CONCLUSIONS: HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. TRIAL REGISTRATION: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).


Asunto(s)
Cánula/normas , Ventilación no Invasiva/normas , Terapia por Inhalación de Oxígeno/instrumentación , Terapia por Inhalación de Oxígeno/métodos , Enfermedad Pulmonar Obstructiva Crónica/terapia , Anciano , Cánula/estadística & datos numéricos , Estudios de Equivalencia como Asunto , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Ventilación no Invasiva/métodos , Ventilación no Invasiva/estadística & datos numéricos , Terapia por Inhalación de Oxígeno/normas , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Brote de los Síntomas
14.
Respiration ; 99(9): 800-817, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33207357

RESUMEN

Non-invasive ventilation (NIV) has dramatically changed the treatment of both acute and chronic respiratory failure in the last 2 decades. The success of NIV is correlated to the application of the "best ingredients" of a patient's "tailored recipe," including the appropriate choice of the selected candidate, the ventilator setting, the interface, the expertise of the team, and the education of the caregiver. The choice of the interface is crucial for the success of NIV. Type (oral, nasal, nasal pillows, oronasal, hybrid mask, helmet), size, design, material and headgears may affect the patient's comfort with respect to many aspects, such as air leaks, claustrophobia, skin erythema, eye irritation, skin breakdown, and facial deformity in children. Companies are paying great attention to mask development, in terms of shape, materials, comfort, and leak reduction. Although the continuous development of new products has increased the availability of interfaces and the chance to meet different requirements, in patients necessitating several daily hours of NIV, both in acute and in chronic home setting, the rotational use of different interfaces may remain an excellent strategy to decrease the risk of skin breakdown and to improve patient's tolerance. The aim of the present review was to give the readers a background on mask technology and materials in order to enhance their "knowledge" in making the right choice for the interface to apply during NIV in the different clinical scenarios.


Asunto(s)
Máscaras , Ventilación no Invasiva/instrumentación , Insuficiencia Respiratoria/terapia , Presión de las Vías Aéreas Positiva Contínua/instrumentación , Diseño de Equipo , Humanos , Ventilación no Invasiva/métodos
15.
Eur Respir J ; 54(3)2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31467119

RESUMEN

BACKGROUND: While the role of acute non-invasive ventilation (NIV) has been shown to improve outcome in acute life-threatening hypercapnic respiratory failure in COPD, the evidence of clinical efficacy of long-term home NIV (LTH-NIV) for management of COPD is less. This document provides evidence-based recommendations for the clinical application of LTH-NIV in chronic hypercapnic COPD patients. MATERIALS AND METHODS: The European Respiratory Society task force committee was composed of clinicians, methodologists and experts in the field of LTH-NIV. The committee developed recommendations based on the GRADE (Grading, Recommendation, Assessment, Development and Evaluation) methodology. The GRADE Evidence to Decision framework was used to formulate recommendations. A number of topics were addressed under a narrative format which provides a useful context for clinicians and patients. RESULTS: The task force committee delivered conditional recommendations for four actionable PICO (target population-intervention-comparator-outcome) questions, 1) suggesting for the use of LTH-NIV in stable hypercapnic COPD; 2) suggesting for the use of LTH-NIV in COPD patients following a COPD exacerbation requiring acute NIV 3) suggesting for the use of NIV settings targeting a reduction in carbon dioxide and 4) suggesting for using fixed pressure support as first choice ventilator mode. CONCLUSIONS: Managing hypercapnia may be an important intervention for improving the health outcome of COPD patients with chronic respiratory failure. The task force conditionally supports the application of LTH-NIV to improve health outcome by targeting a reduction in carbon dioxide in COPD patients with persistent hypercapnic respiratory failure. These recommendations should be applied in clinical practice by practitioners that routinely care for chronic hypercapnic COPD patients.


Asunto(s)
Ventilación no Invasiva/normas , Respiración con Presión Positiva/normas , Enfermedad Pulmonar Obstructiva Crónica/terapia , Neumología/normas , Progresión de la Enfermedad , Europa (Continente) , Medicina Basada en la Evidencia , Servicios de Atención de Salud a Domicilio , Humanos , Hipercapnia/terapia , Guías de Práctica Clínica como Asunto , Insuficiencia Respiratoria/terapia , Resultado del Tratamiento
16.
BMC Pulm Med ; 16(1): 150, 2016 11 15.
Artículo en Inglés | MEDLINE | ID: mdl-27846872

RESUMEN

Acute respiratory failure is a frequent complication in elderly patients especially if suffering from chronic cardio-pulmonary diseases. Non-invasive mechanical ventilation constitutes a successful therapeutic tool in the elderly as, like in younger patients, it is able to prevent endotracheal intubation in a wide range of acute conditions; moreover, this ventilator technique is largely applied in the elderly in whom invasive mechanical ventilation is considered not appropriated. Furthermore, the integration of new technological devices, ethical issues and environment of treatment are still largely debated in the treatment of acute respiratory failure in the elderly.This review aims at reporting and critically analyzing the peculiarities in the management of acute respiratory failure in elderly people, the role of noninvasive mechanical ventilation, the potential advantages of applying alternative or integrated therapeutic tools (i.e. high-flow nasal cannula oxygen therapy, non-invasive and invasive cough assist devices and low-flow carbon-dioxide extracorporeal systems), drawbacks in physician's communication and "end of life" decisions. As several areas of this topic are not supported by evidence-based data, this report takes in account also "real-life" data as well as author's experience.The choice of the setting and of the timing of non-invasive mechanical ventilation in elderly people with advanced cardiopulmonary disease should be carefully evaluated together with the chance of using integrated or alternative supportive devices. Last but not least, economic and ethical issues may often challenges the behavior of the physicians towards elderly people who are hospitalized for acute respiratory failure at the end stage of their cardiopulmonary and neoplastic diseases.


Asunto(s)
Ventilación no Invasiva/métodos , Insuficiencia Respiratoria/terapia , Cuidado Terminal/normas , Enfermedad Aguda , Anciano , Broncoscopía , Cánula , Anciano Frágil , Humanos , Intubación Intratraqueal
18.
Eur Respir J ; 45(3): 691-9, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25504992

RESUMEN

The choice of the interface for noninvasive ventilation (NIV) is a key factor in NIV success. We hypothesised that a new helmet specifically design to improve performance in hypercapnic patients would be clinically equivalent to a standard oronasal mask. In a multicentre, short-term, physiological, randomised trial in chronic obstructive pulmonary disease patients facing an acute hypercapnic respiratory failure episode, we compared the changes in arterial blood gases (ABGs) and tolerance score obtained using the helmet or mask, and, as secondary end-points, dyspnoea, vital signs, early NIV discontinuation and rate of intubation. 80 patients were randomly assigned to receive NIV either with the helmet (n=39) or mask (n=41), using an intensive care unit ventilator. Compared with baseline, in the first 6 h, NIV improved ABGs, dyspnoea and respiratory rate (p<0.05) in both groups. Changes in ABGs and discomfort were similar with the two groups, while dyspnoea decreased more (p<0.005) using the mask. The rate of intubation and the need for interface change during the whole period of NIV were very low and not different between groups. The new helmet may be a valid alternative to a mask in improving ABGs and achieving a good tolerance during an episode of acute hypercapnic respiratory failure.


Asunto(s)
Dispositivos de Protección de la Cabeza , Hipercapnia , Máscaras , Ventilación no Invasiva , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Insuficiencia Respiratoria , Anciano , Anciano de 80 o más Años , Análisis de los Gases de la Sangre/métodos , Investigación sobre la Eficacia Comparativa , Femenino , Humanos , Hipercapnia/diagnóstico , Hipercapnia/etiología , Hipercapnia/terapia , Unidades de Cuidados Intensivos/estadística & datos numéricos , Intubación Intratraqueal/estadística & datos numéricos , Masculino , Monitoreo Fisiológico/métodos , Ventilación no Invasiva/efectos adversos , Ventilación no Invasiva/instrumentación , Ventilación no Invasiva/métodos , Prioridad del Paciente/estadística & datos numéricos , Insuficiencia Respiratoria/diagnóstico , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/terapia , Resultado del Tratamiento
20.
COPD ; 12(3): 315-9, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25093624

RESUMEN

Nocardia is an opportunistic pathogen and Pulmonary Nocardiosis (PN) occurred in more than half of the cases in subjects with immuno-suppressed status. COPD is one of the most common comorbidity observed in immuno-competent patients with PN. In this perspective study, we report the clinical patterns, the outcomes and the comorbidities of all cases of PN admitted in our Unit in the years 1999-2012. Among 6545 patients admitted in our Unit during the study time, we identified PN in 4 patients. COPD was coexistent in 3 out of 4 cases. A delayed time for the diagnosis was observed. Clinical-radiological improvement was detected in all cases after one month of specific anti-PN therapy. According to our experience, PN is a rare disease that should be suspected also in immuno-competent patients. COPD is confirmed to be a risk factor for the development of PN, probably due to reduced respiratory defenses and prolonged steroid therapy.


Asunto(s)
Nocardiosis/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Anciano , Anciano de 80 o más Años , Antibacterianos/uso terapéutico , Diagnóstico Tardío , Quimioterapia Combinada , Femenino , Hospitalización , Humanos , Huésped Inmunocomprometido , Pulmón/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Nocardiosis/tratamiento farmacológico , Radiografía , Estudios Retrospectivos
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