Safety and Diagnostic Yield of Medical Pleuroscopy (MP) Performed under Balanced Analgosedation by a Pneumological Team Compared to Video-Assisted Thoracic Surgery (VATS): A Retrospective Controlled Real-Life Study (TORAPO).

INTRODUCTION: Medical pleuroscopy (MP) is an invasive technique that provides access to the pleural space with a rigid or semi-rigid work instrument, allowing for visualization and the obtaining of bioptic pleural samples. Using pulmonologist-based analgosedation to perform pleuroscopy is still debated for safety reasons. The aim of this real-life study is to demonstrate the safety and diagnostic yield of MP performed under balanced analgosedation by a pulmonologist team with expertise in the management of critically ill patients in the respiratory intensive care unit (RICU) and interventional pulmonology unit as compared to video-assisted thoracic surgery (VATS) performed by a thoracic surgeon team under anesthesiologist-based analgosedation. METHODS: In this multicentric retrospective controlled study, the inclusion criteria were patients older than 18 years old with pleural effusion of unknown diagnosis consecutively admitted in the years 2017-2022 to the pulmonology unit and RICU of San Donato Hospital in Arezzo (Italy, Tuscany) and to the thoracic surgery unit of Santa Maria Le Scotte in Siena (Italy, Tuscany) to undergo, respectively, MP under balanced propofol-based analgosedation on spontaneous breathing with local anesthesia provided by a pulmonologist team (Group A), and VATS provided by a surgeon team under propofol-based analgosedation managed by an anesthesiologist using invasive mechanical ventilation (IMV) via endotracheal intubation (ETI) (Group B). The primary endpoints were (1) a comparison between the two groups in terms of the diagnostic yield of pleural effusion, and (2) major and minor complications of pleuroscopic procedures. The secondary endpoints were (1) the length of the pleuroscopic procedure; (2) the duration of hospitalization; (3) propofol doses; and (4) the patient's comfort after the procedure assessed using the Visual Analogue Scale (VAS). RESULTS: We enrolled 91 patients in Group A and 116 patients in Group B. A conclusive diagnosis was obtained in 97.8% of Group A vs. 100% of Group B (p = 0.374). Malignant effusion was diagnosed in 59.3% of Group A and in 55.1% of Group B; p = 0.547. No intraoperative or postoperative mortality events or major complications were observed in Group A. The major complications observed in Group B were three major bleeding events (p = 0.079) and one exitus (p = 0.315) not related to the interventional procedure. No significant difference emerged between the two groups in terms of minor complications. The duration of the intervention was significantly lower in Group A (40.0 min ± 12.6 versus 51.5 ± 31.0; p = 0.001). Pain control and, therefore, patient comfort were better in Group A, with an average VAS of 0.34 ± 0.65 versus 2.58 ± 1.26, p < 0.001. The duration of hospitalization was lower in Group B (5.1 ± 2.6 vs. 15.5 ± 8.0, p < 0.001). The average overall dose of propofol administered was significantly lower in Group A (65.6 ± 35.8 mg versus 280 ± 20.0 mg; p < 0.001). CONCLUSIONS: This real-life study shows that the MP performed under propofol-based analgosedation by an independent pneumologist team is a safe and well-tolerated procedure with a diagnostic yield and complication rates similar to those obtained with VATS.

Prone positioning during CPAP therapy in SARS-CoV-2 pneumonia: a concise clinical review.

During the COVID-19 pandemic, the number of patients with hypoxemic acute respiratory failure (ARF) due to SARS-CoV-2 pneumonia threatened to overwhelm intensive care units. To reduce the need for invasive mechanical ventilation (IMV), clinicians tried noninvasive strategies to manage ARF, including the use of awake prone positioning (PP) with continuous positive airway pressure (CPAP). In this article, we review the patho-physiologic rationale, clinical effectiveness and practical issues of the use of PP during CPAP in non-intubated, spontaneously breathing patients affected by SARS-CoV-2 pneumonia with ARF. Use of PP during CPAP appears to be safe and feasible and may have a lower rate of adverse events compared to IMV. A better response to PP is observed among patients in early phases of acute respiratory distress syndrome. While PP during CPAP may improve oxygenation, the impact on the need for intubation and mortality remains unclear. It is possible to speculate on the role of PP during CPAP in terms of improvement of ventilation mechanics and reduction of strain stress.

Prolonged higher dose methylprednisolone versus conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS).

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.

Pulmonologist-Administered Balanced Propofol Analgosedation during Interventional Procedures: An Italian Real-Life Study on Comfort and Safety.

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.

The Italian Version of the Severe Respiratory Insufficiency Questionnaire.

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.

Clinical Value of Bronchoscopy in Acute Respiratory Failure.

Bronchoscopy may be considered the "added value" in the diagnostic and therapeutic pathway of different clinical scenarios occurring in acute respiratory critically ill patients. Rigid bronchoscopy is mainly employed in emergent clinical situations due to central airways obstruction, haemoptysis, and inhaled foreign body. Flexible bronchoscopy (FBO) has larger fields of acute applications. In intensive care settings, FBO is useful to facilitate intubation in difficult airways, guide percutaneous dilatational tracheostomy, and mucous plugs causing lobar/lung atelectasis. FBO plays a central diagnostic role in acute respiratory failure caused by intra-thoracic tumors, interstitial lung diseases, and suspected severe pneumonia. "Bronchoscopic" sampling has to be considered when "non-invasive" techniques are not diagnostic in suspected ventilator-associated pneumonia and in non-ventilated immunosuppressed patients. The combined use of either noninvasive ventilation (NIV) or High-flow nasal cannula (HFNC) with bronchoscopy is useful in different scenarios; the largest body of proven successful evidence has been found for NIV-supported diagnostic FBO in non-ventilated high risk patients to prevent and avoid intubation. The expected diagnostic/therapeutic goals of acute bronchoscopy should be balanced against the potential severe risks (i.e., cardio-pulmonary complications, bleeding, and pneumothorax). Expertise of the team is fundamental to achieve the best rate of success with the lowest rate of complications of diagnostic and therapeutic bronchoscopic procedures in acute clinical circumstances.

A case of endobronchial actinomycosis as a challenging cause of lung atelectasis.

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.

Material and Technology: Back to the Future for the Choice of Interface for Non-Invasive Ventilation - A Concise Review.

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.

Prolonged Low-Dose Methylprednisolone in Patients With Severe COVID-19 Pneumonia.

BACKGROUND: In hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia, progression to acute respiratory failure requiring invasive mechanical ventilation (MV) is associated with significant morbidity and mortality. Severe dysregulated systemic inflammation is the putative mechanism. We hypothesize that early prolonged methylprednisolone (MP) treatment could accelerate disease resolution, decreasing the need for intensive care unit (ICU) admission and mortality. METHODS: We conducted a multicenter observational study to explore the association between exposure to prolonged, low-dose MP treatment and need for ICU referral, intubation, or death within 28 days (composite primary end point) in patients with severe COVID-19 pneumonia admitted to Italian respiratory high-dependency units. Secondary outcomes were invasive MV-free days and changes in C-reactive protein (CRP) levels. RESULTS: Findings are reported as MP (n = 83) vs control (n = 90). The composite primary end point was met by 19 vs 40 (adjusted hazard ratio [aHR], 0.41; 95% CI, 0.24-0.72). Transfer to ICU and invasive MV were necessary in 15 vs 27 (P = .07) and 14 vs 26 (P = .10), respectively. By day 28, the MP group had fewer deaths (6 vs 21; aHR, 0.29; 95% CI, 0.12-0.73) and more days off invasive MV (24.0 ±â€…9.0 vs 17.5 ±â€…12.8; P = .001). Study treatment was associated with rapid improvement in PaO2:FiO2 and CRP levels. The complication rate was similar for the 2 groups (P = .84). CONCLUSION: In patients with severe COVID-19 pneumonia, early administration of prolonged MP treatment was associated with a significantly lower hazard of death (71%) and decreased ventilator dependence. Treatment was safe and did not impact viral clearance. A large randomized controlled trial (RECOVERY trial) has been performed that validates these findings. Clinical trial registration. ClinicalTrials.gov NCT04323592.

Feasibility and clinical impact of out-of-ICU noninvasive respiratory support in patients with COVID-19-related pneumonia.

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.