SARS-CoV-2 pneumonia and Eisenmenger's Syndrome: doubling the challenge.

Eisenmenger's syndrome (ES) is the most severe phenotype of pulmonary arterial hypertension (PAH) secondary to congenital heart disease. In these cases, a significant systemic-to-pulmonary (left-to-right) shunting triggers the development of pulmonary vascular disease (PVD) and pulmonary hypertension. In cases of acute hypoxemic respiratory failure in patients with ES, high flow nasal cannula (HFNC) oxygen therapy should be considered as a first-line approach in order to avoid pulmonary complications and right ventricular overload related to positive pressure ventilation. Here, we report a case of HFNC use in a patient with COVID-19 infection and ES.

Peri-partum respiratory management of pregnant women with neuro-muscular disorders: a prospective observational study (IT-NEUMA-Pregn study).

BACKGROUND: Pregnant women with neuromuscular diseases (NMDs) often display respiratory muscle impairment which increases the risk for pulmonary complications (PCs). The aim of this study was to identify pregnant NMDs patients with pulmonary risk factors and to apply in these women non-invasive ventilation (NIV) combined with mechanical insufflation-exsufflation (MI-E) in the peri-partum period. METHODS: We conducted a multicenter observational study on women with NMDs undergoing cesarean section or spontaneous labor in a network of 7 national hospitals. In these subjects we applied a protocol for screening and preventing PCs, and we evaluated PCs rate, maternal and neonatal outcome. RESULTS: Twenty-four patients out of the 94 enrolled pregnant women were at risk for PCs and were trained or retrained to use NIV and/or MI-E before delivery. After delivery, 17 patients required NIV with or without MI-E. Despite nine out of the 24 women at pulmonary risk developed postpartum PCs, none of them needed reintubation nor tracheostomy. In addition, the average birth weight and Apgar score were normal. Only one patient without pulmonary risk factors developed postpartum PCs. CONCLUSION: This study showed the feasibility of applying a protocol for screening and treating pregnant NMDs women with pulmonary risk. Despite a PCs rate of 37% was observed in these patients, maternal and neonatal outcome were favorable.

Postprandial hypotension as a predictor of respiratory failure in patients with foodborne botulinum intoxication - a case-control study in outbreak investigation.

OBJECTIVES: Botulism is a rare syndrome characterized by acute, flaccid paralysis with possible involvement of respiratory muscle-producing pump failure requiring mechanical ventilation. A predominance of autonomic involvement can occur. METHODS: We enrolled patients affected by foodborne botulism during an outbreak. All patients underwent the detection of the toxin in stool specimens, and 24-hour ambulatory blood pressure monitoring (ABPM). A blinded expert operator analyzed ABPM data for the diagnosis of hypertension and postprandial hypotension (PPH). RESULTS: Twenty male patients met the inclusion and exclusion criteria. Thirty-four healthy subjects matched for sex and age were enrolled as a control group. PPH was significantly more frequent in the botulin group than in healthy subjects (40% vs 2.9%, P <0.0001). At the logistic regression, the probability that patients affected by botulinum could require ventilation was increased by 733% (adjusted odds ratio: 8.33) when PPH is encountered. CONCLUSIONS: The likelihood of resorting to ventilation in subjects with botulinum intoxication was seven times greater in patients presenting PPH. These results could allow the prompt identification of patients at high risk for requiring ventilation.

A pragmatic, open-label, multi-center, randomized controlled clinical trial on the rotational use of interfaces vs standard of care in patients treated with noninvasive positive pressure ventilation for acute hypercapnic respiratory failure: the ROTAtional-USE of interface STUDY (ROTA-USE STUDY).

BACKGROUND: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers. METHODS: The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h. DISCUSSION: The development of pressure ulcers is a common side effect of NIV that negatively affects the patients' comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.

High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial.

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.

Personalized Noninvasive Respiratory Support in the Perioperative Setting: State of the Art and Future Perspectives.

Background: Noninvasive respiratory support (NRS), including high-flow nasal oxygen therapy (HFNOT), noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP), are routinely used in the perioperative period. Objectives: This narrative review provides an overview on the perioperative use of NRS. Preoperative, intraoperative, and postoperative respiratory support is discussed, along with potential future areas of research. Results: During induction of anesthesia, in selected patients at high risk of difficult intubation, NIV is associated with improved gas exchange and reduced risk of postoperative respiratory complications. HFNOT demonstrated an improvement in oxygenation. Evidence on the intraoperative use of NRS is limited. Compared with conventional oxygenation, HFNOT is associated with a reduced risk of hypoxemia during procedural sedation, and recent data indicate a possible role for HFNOT for intraoperative apneic oxygenation in specific surgical contexts. After extubation, "preemptive" NIV and HFNOT in unselected cohorts do not affect clinical outcome. Postoperative "curative" NIV in high-risk patients and among those exhibiting signs of respiratory failure can reduce reintubation rate, especially after abdominal surgery. Data on postoperative "curative" HFNOT are limited. Conclusions: There is increasing evidence on the perioperative use of NRS. Use of NRS should be tailored based on the patient's specific characteristics and type of surgery, aimed at a personalized cost-effective approach.

The right interface for the right patient in noninvasive ventilation: a systematic review.

INTRODUCTION: Research in the field of noninvasive ventilation (NIV) has contributed to the development of new NIV interfaces. However, interface tolerance plays a crucial role in determining the beneficial effects of NIV therapy. AREAS COVERED: This systematic review explores the most significant scientific research on NIV interfaces, with a focus on the potential impact that their design might have on treatment adherence and clinical outcomes. The rationale on the choice of the right interface among the wide variety of devices that are currently available is discussed here. EXPERT OPINION: The paradigm 'The right mask for the right patient' seems to be difficult to achieve in real life. Ranging from acute to chronic settings, the gold standard should include the tailoring of NIV interfaces to patients' needs and preferences. However, such customization may be hampered by issues of economic nature. High production costs and the increasing demand represent consistent burdens and have to be considered when dealing with patient-tailored NIV interfaces. New research focusing on developing advanced and tailored NIV masks should be prioritized; indeed, interfaces should be designed according to the specific patient and clinical setting where they need to be used.

Intensive care medicine in Europe: perspectives from the European Society of Anaesthesiology and Intensive Care.

BACKGROUND: Anaesthesiology represents a rapidly evolving medical specialty in global healthcare, currently covering advanced peri-operative, pre-hospital and in-hospital critical emergency management (CREM), intensive care medicine (ICM) and pain management. The aim of the European Society of Anaesthesiology and Intensive Care (ESAIC) is to develop and promote a coordinated interdisciplinary and multidisciplinary European network of Anaesthesiology and Intensive Care Medicine (AICM) societies for improvement of patient safety and outcome, and to enhance political and public awareness of the role of anaesthesiologists all over Europe. The ESAIC promotes coordinated interdisciplinary and multidisciplinary care for severely compromised patients, based on the European training requirements (ETR) within the European Union of Medical Specialists (UEMS). METHODS: To define the current situation of AICM in Europe, a survey was sent in April 2019 to the ESAIC Council and the ESAIC National Anaesthesiologists Societies Committee (NASC) members. The survey posed questions regarding the year of foundation, the inclusion of ICM in the society name, and if, and to what extent, various kinds (postoperative, general, specific, mixed) of national ICUs are being run by differing medical specialties. The study data were compiled and analysed by the ESAIC Board, Council and NASC in December 2019. RESULTS AND CONCLUSION: Amongst the 42 European national societies surveyed (41 members of ESAIC-NASC plus Luxembourg), nineteen (45%) also include terms related to critical care medicine or ICM in their names, seven (17%) include terms related to reanimation and three (7%) to resuscitation. In recent years, several national societies revised their names to better reflect their gradual embrace of peri-operative medicine, ICM, CREM and pain management. Approximately 70% of ICU beds in Europe, and 100% in Scandinavia, are being run by anaesthesiologists, the remaining 30% being managed by physicians from other surgical or medical specialties. To emphasise future needs and resources of European AICM, the ESAIC drafted an ICM roadmap in terms of clinical practice, organisation of healthcare, interprofessional and interdisciplinary collaboration, patient safety, outcome and empowerment, professional working conditions, and changes in research, teaching and training required to meet future challenges and expectations.

Nasal pressure swings as the measure of inspiratory effort in spontaneously breathing patients with de novo acute respiratory failure.

BACKGROUND: Excessive inspiratory effort could translate into self-inflicted lung injury, thus worsening clinical outcomes of spontaneously breathing patients with acute respiratory failure (ARF). Although esophageal manometry is a reliable method to estimate the magnitude of inspiratory effort, procedural issues significantly limit its use in daily clinical practice. The aim of this study is to describe the correlation between esophageal pressure swings (ΔPes) and nasal (ΔPnos) as a potential measure of inspiratory effort in spontaneously breathing patients with de novo ARF. METHODS: From January 1, 2021, to September 1, 2021, 61 consecutive patients with ARF (83.6% related to COVID-19) admitted to the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) and candidate to escalation of non-invasive respiratory support (NRS) were enrolled. Clinical features and tidal changes in esophageal and nasal pressure were recorded on admission and 24 h after starting NRS. Correlation between ΔPes and ΔPnos served as primary outcome. The effect of ΔPnos measurements on respiratory rate and ΔPes was also assessed. RESULTS: ΔPes and ΔPnos were strongly correlated at admission (R2 = 0.88, p < 0.001) and 24 h apart (R2 = 0.94, p < 0.001). The nasal plug insertion and the mouth closure required for ΔPnos measurement did not result in significant change of respiratory rate and ΔPes. The correlation between measures at 24 h remained significant even after splitting the study population according to the type of NRS (high-flow nasal cannulas [R2 = 0.79, p < 0.001] or non-invasive ventilation [R2 = 0.95, p < 0.001]). CONCLUSIONS: In a cohort of patients with ARF, nasal pressure swings did not alter respiratory mechanics in the short term and were highly correlated with esophageal pressure swings during spontaneous tidal breathing. ΔPnos might warrant further investigation as a measure of inspiratory effort in patients with ARF. TRIAL REGISTRATION: NCT03826797 . Registered October 2016.

Association between night-time extubation and clinical outcomes in adult patients: A systematic review and meta-analysis.

BACKGROUND: Whether night-time extubation is associated with clinical outcomes is unclear. OBJECTIVE: The aim of this systematic review and meta-analysis was to evaluate the association between night-time extubation and the reintubation rate, mortality, ICU and in-hospital length of stay in adult patients, compared with daytime extubation. DESIGN: A systematic review and meta-analysis. DATA SOURCES: PubMed, EMBASE, CINAHL and Web of Science from inception to 2 January 2021 (PROSPERO registration - CRD42020222812). ELIGIBILITY CRITERIA: Randomised, quasi and cluster randomised, and nonrandomised studies describing associations between adult patients' outcomes and time of extubation (daytime/night-time) in intensive care or postanaesthesia care units. RESULTS: Seven retrospective studies were included in the systematic review and meta-analysis, for a total of 293 663 patients. All the studies were performed in United States (USA). All the studies were judged at moderate risk of bias for reintubation and mortality. The analyses were conducted with random effects models. The analyses from adjusted estimates demonstrated no association between night-time extubation and increased risk of either reintubation (OR 1.00; 95% CI 0.88 to 1.13; P = 1.00; I2 = 66%; low-certainty evidence) or all-cause mortality at the longest available follow-up (OR 1.11; 95% CI 0.87 to 1.42; P = 0.39; I2 = 79%; low-certainty evidence), in comparison with daytime extubation. Analyses from unadjusted data for reintubation, mortality and ICU or in-hospital length of stay showed no significant association with night-time extubation. Analyses based on type of admission, number of centres or duration of mechanical ventilation showed no significant subgroup effects. CONCLUSION: Night-time extubation of adult patients was not associated with higher adjusted risks for reintubation or death, in comparison with daytime extubation, but the certainty of the evidence was low.

ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure.

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.

Cardiac arrest during a diving session: A case report and differential diagnosis.

We report a case of out-of-hospital cardiac arrest occurred in a 61-year-old recreational female diver. After resuscitation, the patient was referred to the hospital. With data provided by witnesses and appropriate medical investigations, drowning related to a failed rebreather system was the most plausible explanation. Patient outcome was favorable.

Ventilator-Associated Pneumonia in Patients with COVID-19: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to estimate the pooled occurrence of ventilator-associated pneumonia (VAP) among patients admitted to an intensive care unit with COVID-19 and mortality of those who developed VAP. We performed a systematic search on PubMed, EMBASE and Web of Science from inception to 2nd March 2021 for nonrandomized studies specifically addressing VAP in adult patients with COVID-19 and reporting data on at least one primary outcome of interest. Random effect single-arm meta-analysis was performed for the occurrence of VAP and mortality (at the longest follow up) and ICU length of stay. Twenty studies were included in the systematic review and meta-analysis, for a total of 2611 patients with at least one episode of VAP. The pooled estimated occurrence of VAP was of 45.4% (95% C.I. 37.8-53.2%; 2611/5593 patients; I2 = 96%). The pooled estimated occurrence of mortality was 42.7% (95% C.I. 34-51.7%; 371/946 patients; I2 = 82%). The estimated summary estimated metric mean ICU LOS was 28.58 days (95% C.I. 21.4-35.8; I2 = 98%). Sensitivity analysis showed that patients with COVID-19 may have a higher risk of developing VAP than patients without COVID-19 (OR 3.24; 95% C.I. 2.2-4.7; P = 0.015; I2 = 67.7%; five studies with a comparison group).

Performance of EasyBreath Decathlon Snorkeling mask for delivering continuous positive airway pressure.

During the COVID-19 pandemic, the need for noninvasive respiratory support devices has dramatically increased, sometimes exceeding hospital capacity. The full-face Decathlon snorkeling mask, EasyBreath (EB mask), has been adapted to deliver continuous positive airway pressure (CPAP) as an emergency respiratory interface. We aimed to assess the performance of this modified EB mask and to test its use during different gas mixture supplies. CPAP set at 5, 10, and 15 cmH2O was delivered to 10 healthy volunteers with a high-flow system generator set at 40, 80, and 120 L min-1 and with a turbine-driven ventilator during both spontaneous and loaded (resistor) breathing. Inspiratory CO2 partial pressure (PiCO2), pressure inside the mask, breathing pattern and electrical activity of the diaphragm (EAdi) were measured at all combinations of CPAP/flows delivered, with and without the resistor. Using the high-flow generator set at 40 L min-1, the PiCO2 significantly increased and the system was unable to maintain the target CPAP of 10 and 15 cmH2O and a stable pressure within the respiratory cycle; conversely, the turbine-driven ventilator did. EAdi significantly increased with flow rates of 40 and 80 L min-1 but not at 120 L min-1 and with the turbine-driven ventilator. EB mask can be safely used to deliver CPAP only under strict constraints, using either a high-flow generator at a flow rate greater than 80 L min-1, or a high-performance turbine-driven ventilator.

Implementation of noninvasive neurally adjusted ventilatory assist in pediatric acute respiratory failure: a controlled before-after quality improvement study.

BACKGROUNDS: Pediatric noninvasive neurally adjusted ventilatory assist (NIV-NAVA) has been shown to improve patient-ventilator interaction but no data on clinical outcomes are available. Aim of this study was to compare NIV-NAVA with noninvasive pressure support (NIV-PS) in children with acute hypoxemic respiratory failure (AHRF), in a single-center before-after study. A cohort of thirty-four NIV-PS patients (before group) admitted to our PICU within the 2 years prior NAVA introduction was compared with a cohort of thirty children treated with NIV-NAVA during implementation phase (after group). The primary end-point was intubation rate between groups. Days on mechanical ventilation, number of invasive devices, nosocomial infections, PICU/hospital length of stay (LOS), and physiological parameters at 2 and 24 h after admission were considered. RESULTS: Intubation rate was lower in the NIV-NAVA group as compared to the NIV-PS group (p = 0.006). Patients treated with NIV-NAVA required fewer invasive devices (p = 0.032) and had lower incidence of ventilator-acquired pneumonia (p = 0.004) and shorter PICU (p = 0.032) and hospital LOS (p = 0.013). At 2 h, NIV-NAVA compared with NIV-PS resulted in higher paO2:FIO2 (p = 0.017), lower paCO2 (p = 0.002), RR (p = 0.026), and HR (p = 0.009). CONCLUSIONS: Early NIV-NAVA vs NIV-PS was associated to lower intubation rate and shorter PICU and hospital LOS. Further studies are needed in order to confirm these preliminary data.

An Italian Guidance Model for the Management of Suspected or Confirmed COVID-19 Patients in the Primary Care Setting.

An outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 started in China's Hubei province at the end of 2019 has rapidly become a pandemic. In Italy, a great number of patients was managed in primary care setting and the role of general practitioners and physicians working in the first-aid emergency medical service has become of utmost importance to coordinate the network between the territory and hospitals during the pandemic. Aim of this manuscript is to provide a guidance model for the management of suspected, probable, or confirmed cases of SARS-CoV-2 infection in the primary care setting, from diagnosis to treatment, applying also the recommendations of the Italian Society of General Medicine. Moreover, this multidisciplinary contribution would analyze and synthetize the preventive measures to limit the spread of SARS-CoV-2 infection in the general population as well as the perspective for vaccines.

High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial.

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).

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.