The COVID-HIGH RANDOMIZED CLINICAL TRIAL

The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure. ClinicalTrials.gov Identifier: NCT04655638

Emotional status and fear in patients scheduled for elective surgery during COVID-19 pandemic: a nationwide cross-sectional survey (COVID-SURGERY)

The aim of this multicentre nationwide prospective cross-sectional survey was to evaluate the impact of pandemic on emotional status and fear of SARS-CoV-2 contagion in a cohort of elective surgical patients in Italy, scheduled for surgery during the COVID-19 pandemic.

Variation in Communication and Family Visiting Policies in Italian Intensive Care Units during the COVID-19 Pandemic: A Secondary Analysis of the COVISIT International Survey

Background: During COVID-19 pandemic, restrictions to in-person visiting of caregivers to patients admitted to intensive care units (ICU) were applied in many countries. Our aim was to describe the variations in communication and family visiting policies in Italian ICUs during the pandemic. Methods: A secondary analysis from the COVISIT international survey was conducted, focusing on data from Italy. Results: Italian ICUs provided 118 (18%) responses out of 667 responses collected worldwide. A total of 12 Italian ICUs were at the peak of COVID-19 admissions at the time of the survey and 42/118 had 90% or more of patients admitted to ICU affected by COVID-19. During the COVID-19 peak, 74% of Italian ICUs adopted a no-in-person-visiting policy. This remained the most common strategy (67%) at the time of the survey. Information to families was provided by regular phone calls (81% in Italy versus 47% for the rest of the world). Virtual visiting was available for 69% and most commonly performed using devices provided by the ICU (71% in Italy versus 36% outside Italy). Conclusion: Our study showed that restrictions to the ICU applied during the COVID-19 pandemic were still in use at the time of the survey. The main means of communication with caregivers were telephone and virtual meetings.

Variation in Communication and Family Visiting Policies in Italian Intensive Care Units during the COVID-19 Pandemic: A Secondary Analysis of the COVISIT International Survey.

BACKGROUND: During COVID-19 pandemic, restrictions to in-person visiting of caregivers to patients admitted to intensive care units (ICU) were applied in many countries. Our aim was to describe the variations in communication and family visiting policies in Italian ICUs during the pandemic. METHODS: A secondary analysis from the COVISIT international survey was conducted, focusing on data from Italy. RESULTS: Italian ICUs provided 118 (18%) responses out of 667 responses collected worldwide. A total of 12 Italian ICUs were at the peak of COVID-19 admissions at the time of the survey and 42/118 had 90% or more of patients admitted to ICU affected by COVID-19. During the COVID-19 peak, 74% of Italian ICUs adopted a no-in-person-visiting policy. This remained the most common strategy (67%) at the time of the survey. Information to families was provided by regular phone calls (81% in Italy versus 47% for the rest of the world). Virtual visiting was available for 69% and most commonly performed using devices provided by the ICU (71% in Italy versus 36% outside Italy). CONCLUSION: Our study showed that restrictions to the ICU applied during the COVID-19 pandemic were still in use at the time of the survey. The main means of communication with caregivers were telephone and virtual meetings.

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.

Facepiece filtering respirators with exhalation valve should not be used in the community to limit SARS-CoV-2 diffusion

During normal speech, a huge number of droplets are produced, and face covering may be effective in limiting the distance reached by the droplets, potentially reducing the transmission of the virus from individuals who are unaware that they are infected.1 Face covering with masks or tissue has been widely recommended as a complementary measure to reduce the infection rate in the community by limiting the excretion of droplets from asymptomatic or presymptomatic individuals.2 In this context, some governments are ordering face covering, especially during activities when social distancing is impossible or difficult (eg, using public transportation and visiting grocery stores or supermarkets, etc).2,3 Such measures should be intended as a protection towards the community and not as self-protection. FFRs are disposable filtering media, designed to provide the wearer an inward protection from inhaling contaminants conveyed by respiratory droplets or aerosols.4 On one hand, this ‘panic buying’ of FFRs may have contributed to the lack of supplies available for those employed in risky settings, such as healthcare workers frequently exposed to aerosol generating procedures, and it has also likely encourages counterfeiting.5 On the other hand, the uncontrolled sale of FFRs to people who are unaware of their specific features and are untrained in their use can create additional risks: incorrect doffing procedures can increase cross contamination;a false perception of safety can reduce the compliance to other measures (ie, hand hygiene, respiratory etiquette, social distancing);and even worse, the use of FFRs with exhalation valves in the community may be an additional and underrecognized transmission source. The European Centres for Disease Prevention and Control (ECDC) and Africa Centre for Disease Prevention and Control have provided clear statements against their use in the community setting.7,8 The US Centers for Disease Prevention and Control (CDC) recommended against their use in healthcare settings where a sterile field must be maintained, thus implying that the outward protection is not provided by FFRs.9 Recently, the City and County of San Francisco explicitly listed respirators with one-way valves among those forbidden for use in the community, clarifying that they ‘allow droplets out of the mask, putting others nearby at risk,’ thus not complying with the face-covering order.10 Communication campaigns should aim to promote the wearing of masks as a source control measure and to increase awareness that FFR supplies are already insufficient to protect highly exposed workers.

Level of Diffusion and Training of Lung Ultrasound during the COVID-19 Pandemic - A National Online Italian Survey (ITALUS) from the Lung Ultrasound Working Group of the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI).

PURPOSE: The goal of this survey was to describe the use and diffusion of lung ultrasound (LUS), the level of training received before and during the COVID-19 pandemic, and the clinical impact LUS has had on COVID-19 cases in intensive care units (ICU) from February 2020 to May 2020. MATERIALS AND METHODS: The Italian Lung Ultrasound Survey (ITALUS) was a nationwide online survey proposed to Italian anesthesiologists and intensive care physicians carried out after the first wave of the COVID-19 pandemic. It consisted of 27 questions, both quantitative and qualitative. RESULTS: 807 responded to the survey. The median previous LUS experience was 3 years (IQR 1.0-6.0). 473 (60.9 %) reported having attended at least one training course on LUS before the COVID-19 pandemic. 519 (73.9 %) reported knowing how to use the LUS score. 404 (52 %) reported being able to use LUS without any supervision. 479 (68.2 %) said that LUS influenced their clinical decision-making, mostly with respect to patient monitoring. During the pandemic, the median of patients daily evaluated with LUS increased 3-fold (p < 0.001), daily use of general LUS increased from 10.4 % to 28.9 % (p < 0.001), and the daily use of LUS score in particular increased from 1.6 % to 9.0 % (p < 0.001). CONCLUSION: This survey showed that LUS was already extensively used during the first wave of the COVID-19 pandemic by anesthesiologists and intensive care physicians in Italy, and then its adoption increased further. Residency programs are already progressively implementing LUS teaching. However, 76.7 % of the sample did not undertake any LUS certification.

Emotional status and fear in patients scheduled for elective surgery during COVID-19 pandemic: a nationwide cross-sectional survey (COVID-SURGERY).

BACKGROUND: Fragmented data exist on the emotional and psychological distress generated by hospital admission during the pandemic in specific populations of patients, and no data exists on patients scheduled for surgery. The aim of this multicentre nationwide prospective cross-sectional survey was to evaluate the impact of pandemic on emotional status and fear of SARS-CoV-2 contagion in a cohort of elective surgical patients in Italy, scheduled for surgery during the COVID-19 pandemic. RESULTS: Twenty-nine Italian centres were involved in the study, for a total of 2376 patients surveyed (mean age of 58 years ± 16.61; 49.6% males). The survey consisted of 28 total closed questions, including four study outcome questions. More than half of patients had at least one chronic disease (54%), among which cardiovascular diseases were the commonest (58%). The most frequent type of surgery was abdominal (20%), under general anaesthesia (64%). Almost half of the patients (46%) declared to be frightened of going to the hospital for routine checkups; 55% to be afraid of getting SARS-CoV-2 infection during hospitalization and 62% were feared of being hospitalised without seeing family members. Having an oncological disease and other patient-related, centre-related or perioperative factors were independently associated with an increased risk of fear of SARS-CoV-2 infection during hospitalization and of being hospitalised without seeing family members. A previous infection due to SARS-COV-2 was associated with a reduced risk of worse emotional outcomes and fear of SARS-CoV-2 infection during hospitalization. Patients who showed the most emotionally vulnerable profile (e.g. use of sleep-inducing drugs, higher fear of surgery or anaesthesia) were at higher risk of worse emotional status towards the hospitalization during COVID-19 pandemic. Being operated in hospitals with lower surgical volume and with COVID-19 wards was associated with worse emotional status and fear of contagion. CONCLUSIONS: Additional fear and worse emotional status may be frequent in patients scheduled for elective surgery during COVID-19 pandemic. More than half of the participants to the survey were worried about not being able to receive family visits. Psychological support may be considered for patients at higher risk of psychological distress to improve perioperative wellbeing during the pandemic.

Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care expert consensus statement on the use of lung ultrasound in critically ill patients with coronavirus disease 2019 (ITACO).

BACKGROUND: To produce statements based on the available evidence and an expert consensus (as members of the Lung Ultrasound Working Group of the Italian Society of Analgesia, Anesthesia, Resuscitation, and Intensive Care, SIAARTI) on the use of lung ultrasound for the management of patients with COVID-19 admitted to the intensive care unit. METHODS: A modified Delphi method was applied by a panel of anesthesiologists and intensive care physicians expert in the use of lung ultrasound in COVID-19 intensive critically ill patients to reach a consensus on ten clinical questions concerning the role of lung ultrasound in the following: COVID-19 diagnosis and monitoring (with and without invasive mechanical ventilation), positive end expiratory pressure titration, the use of prone position, the early diagnosis of pneumothorax- or ventilator-associated pneumonia, the process of weaning from invasive mechanical ventilation, and the need for radiologic chest imaging. RESULTS: A total of 20 statements were produced by the panel. Agreement was reached on 18 out of 20 statements (scoring 7-9; "appropriate") in the first round of voting, while 2 statements required a second round for agreement to be reached. At the end of the two Delphi rounds, the median score for the 20 statements was 8.5 [IQR 8.9], and the agreement percentage was 100%. CONCLUSION: The Lung Ultrasound Working Group of the Italian Society of Analgesia, Anesthesia, Resuscitation, and Intensive Care produced 20 consensus statements on the use of lung ultrasound in COVID-19 patients admitted to the ICU. This expert consensus strongly suggests integrating lung ultrasound findings in the clinical management of critically ill COVID-19 patients.

Palliative Care Principles and Anesthesiology Clinical Practice: Current Perspectives.

BACKGROUND: Palliative care is a person-centered approach aiming to relieve patient's health-related suffering and it is often needed when caring for critically ill patients to manage symptoms and identify goals of care. AIM: To describe the integration of palliative care principles in anesthesiology clinical practice, within and outside the ICU and to analyze the additional challenges that COVID-19 pandemic is posing in this context. METHODS: For the purpose of this review, PubMed database was searched for studies concerning palliative care and end of life care, in contexts involving anesthesiologists and intensivists, published in the last 5 years. RESULTS: Anesthesiologists and intensivists integrate palliative care within their daily practice providing symptoms management as well as family counseling. High-quality communicational skills are fundamental for anesthesiologists and intensivists especially when interfacing with surrogate decision makers in the ICU or with patients in the preoperative setting while discussing goals of care. Coronavirus disease 2019 (COVID-19) pandemic has challenged many aspects of palliative care delivery: reduced family presence within the ICU, communication with families through phone calls or video calls, patient-physician relationship mediated by bulky personal protective equipment and healthcare workers physical and psychological distress due to the increased workload and limitations in resources are some of the most evident. CONCLUSION: Anesthesiologists and intensivists are increasingly facing challenging clinical situations where principles and practice of palliative care have to be applied. In this sense, increasing knowledge on palliative care and providing specific training would allow to deliver high-quality symptom management, family counseling and end of life guidance in critical care settings. COVID-19 pandemic sets additional difficulties to palliative care delivery.

Bloodstream Infections in Hospitalized Patients with COVID-19: A Systematic Review and Meta-Analysis.

BACKGROUND: Little is known about the occurrence of bloodstream infections in hospitalized patients with COVID-19 and the related clinical consequences. The aim of this systematic review and meta-analysis was to estimate the pooled occurrence of BSIs among hospitalized patients with COVID-19 and mortality of this patient population. METHODS: A systematic search was performed on PubMed, EMBASE, and Web of Science from inception to 19 April 2021. The primary outcome was the occurrence of BSIs among hospitalized patients with COVID-19. The secondary outcome was mortality at the longest available follow-up. RESULTS: Forty-six studies met the inclusion criteria, with a total of 42,694 patients evaluated. The estimated occurrence of BSIs was 7.3% (95% CI 4.7-1.1%) among hospitalized patients with COVID-19, with a mortality rate of 41% (95% CI 30%-52.8%). The subgroup analysis conducted on patients admitted to ICU provided an estimated occurrence of 29.6% (95% CI 21.7%-38.8%). A higher occurrence of BSI was observed in patients with COVID-19, in comparison with patients without COVID-19 (OR 2.77; 95% CI 1.53-5.02; p < 0.001). CONCLUSIONS: Our analysis estimated the occurrence of BSIs among hospitalized patients with COVID-19 at around 7%. A four-times higher occurrence was estimated among patients admitted to ICU.

Length of remdesivir treatment in patients with severe COVID-19.

In severe COVID-19, a 5-day remdesivir regimen seems as effective as a 10-day course of treatment and it may be safer. To date, the drug has no clearly proven efficacy over time. https://bit.ly/3tKOuvt.

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).

Mortality after in-hospital cardiac arrest in patients with COVID-19: A systematic review and meta-analysis.

AIM: To estimate the mortality rate, the rate of return of spontaneous circulation (ROSC) and survival with favorable neurological outcome in patients with COVID-19 after in-hospital cardiac arrest (IHCA) and attempted cardiopulmonary resuscitation (CPR). METHODS: PubMed, EMBASE, Web of Science, bioRxiv and medRxiv were surveyed up to 8th February 2021 for studies reporting data on mortality of patients with COVID-19 after IHCA. The primary outcome sought was mortality (in-hospital or at 30 days) after IHCA with attempted CPR. Additional outcomes were the overall rate of IHCA, the rate of non-shockable presenting rhythms, the rate of ROSC and the rate of survival with favorable neurological status. RESULTS: Ten articles were included in the systematic review and meta-analysis, for a total of 1179 COVID-19 patients after IHCA with attempted CPR. The estimated overall mortality rate (in-hospital or at 30 days) was 89.9% (95% Predicted Interval [P.I.] 83.1%-94.2%; 1060/1179 patients; I2 = 82%). The estimated rate of non-shockable presenting rhythms was 89% (95% P.I. 82.8%-93.1%; 1022/1205 patients; I2 = 85%), and the estimated rate of ROSC was 32.9% (95% P.I. 26%-40.6%; 365/1205 patients; I2 = 82%). The estimated overall rate of survival with favorable neurological status at 30 days was 6.3% (95% P.I. 4%-9.7%; 50/851 patients; I2 = 48%). Sensitivity analysis showed that COVID-19 patients had higher risk of death after IHCA than non COVID-19 patients (OR 2.34; 95% C.I. 1.37-3.99; number of studies = 3; 1215 patients). CONCLUSIONS: Although one of three COVID-19 patients undergoing IHCA may achieve ROSC, almost 90% may not survive at 30 days or to hospital discharge.

Mechanical ventilation parameters in critically ill COVID-19 patients: a scoping review.

BACKGROUND: The mortality of critically ill patients with COVID-19 is high, particularly among those receiving mechanical ventilation (MV). Despite the high number of patients treated worldwide, data on respiratory mechanics are currently scarce and the optimal setting of MV remains to be defined. This scoping review aims to provide an overview of available data about respiratory mechanics, gas exchange and MV settings in patients admitted to intensive care units (ICUs) for COVID-19-associated acute respiratory failure, and to identify knowledge gaps. MAIN TEXT: PubMed, EMBASE, and MEDLINE databases were searched from inception to October 30, 2020 for studies providing at least one ventilatory parameter collected within 24 h from the ICU admission. The quality of the studies was independently assessed using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies. A total of 26 studies were included for a total of 14,075 patients. At ICU admission, positive end expiratory pressure (PEEP) values ranged from 9 to 16.5 cm of water (cmH2O), suggesting that high levels of PEEP were commonly used for setting MV for these patients. Patients with COVID-19 are severely hypoxemic at ICU admission and show a median ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ranging from 102 to 198 mmHg. Static respiratory system compliance (Crs) values at ICU admission were highly heterogenous, ranging between 24 and 49 ml/cmH2O. Prone positioning and neuromuscular blocking agents were widely used, ranging from 17 to 81 and 22 to 88%, respectively; both rates were higher than previously reported in patients with "classical" acute respiratory distress syndrome (ARDS). CONCLUSIONS: Available data show that, in mechanically ventilated patients with COVID-19, respiratory mechanics and MV settings within 24 h from ICU admission are heterogeneous but similar to those reported for "classical" ARDS. However, to date, complete data regarding mechanical properties of respiratory system, optimal setting of MV and the role of rescue treatments for refractory hypoxemia are still lacking in the medical literature.

Personal protective equipment use by healthcare workers in intensive care unit during the early phase of COVID-19 pandemic in Italy: a secondary analysis of the PPE-SAFE survey.

BACKGROUND: Italy was the first Western country to be heavily affected by COVID-19. Healthcare workers (HCWs) were exposed to a high risk of occupational infection, partially due to insufficient personal protective equipment (PPE) supplies. This study aimed to describe the practices, availability, training, confidence in PPE use and the adverse effects due to extended PPE use, as reported by HCWs in Italy. We also aimed to provide a comparison between Italian data and those from other countries. METHODS: This study was a secondary analysis of a previously published international study, the PPE-SAFE Survey, conducted in April 2020. Data were analysed from the original study database. RESULTS: We analysed the responses from 380 healthcare workers based in Italy, out of the 2711 respondents to the international survey. Among the Italian respondents, FFP2 and FFP3 respirators or equivalent were the most used masks for routine tasks (respectively 188/380, 50%; and 163/380, 43%). The median time of wearing PPE without taking a break was 5 h [interquartile range (IQR) 4-6], with statistically significant difference from other countries [median 4 h (IQR 2-5) p < 0.0001]. In Italy, 249 out of 380 (65%) HCWs had never performed a formal fit test for a N95 mask or equivalent and 91/380 (24%) never had a partner for donning and doffing procedures. Most of the respondents (299/380, 79%) had received formal training in PPE use at any time. CONCLUSION: Most of the surveyed Italian HCWs reported working at above usual capacity, long shifts with PPE without breaks and routine use in intensive care unit of aerosol protection (e.g. FFP2/FFP3), hazmat suits and face shields/visors. The correct adherence to safety procedures (e.g. donning/doffing in pairs, performing fit test) has substantial scope for improvement in the future.

Prone positioning and convalescent plasma therapy in a critically ill pregnant woman with COVID-19.

Prone positioning is feasible in pregnancy and may have contributed to the positive outcome in this case. Doctors should not be reluctant to move a patient to a prone position just because they are pregnant.

Cardiopulmonary resuscitation in prone position: A scoping review.

INTRODUCTION: The ongoing pandemic of COVID-19 brought to the fore prone positioning as treatment for patients with acute respiratory failure. With the increasing number of patients in prone position, both spontaneously breathing and mechanically ventilated, cardiac arrest in this position is more likely to occur. This scoping review aimed to summarize the available evidence on cardiopulmonary resuscitation in prone position ('reverse CPR') and knowledge or research gaps to be further evaluated. The protocol of this scoping review was prospectively registered on 10th May 2020 in Open Science Framework (https://osf.io/nfuh9). METHODS: We searched PubMed, EMBASE, MEDLINE and pre-print repositories (bioRxiv and medRxiv) for simulation, pre-clinical and clinical studies on reverse CPR until 31st May 2020. RESULTS: We included 1 study on manikins, 31 case reports (29 during surgery requiring prone position) and 2 nonrandomized studies describing reverse CPR. No studies were found regarding reverse CPR in patients with COVID-19. CONCLUSIONS: Even if the algorithms provided by the guidelines on basic and advanced life support remain valid in cardiac arrest in prone position, differences exist in the methods of performing CPR. There is no clear evidence of superiority in terms of effectiveness of reverse compared to supine CPR in patients with cardiac arrest occurring in prone position. The quality of evidence is low and knowledge gaps (e.g. protocols, training of healthcare personnel, devices for skill acquisition) should be fulfilled by further research. Meanwhile, a case-by-case evaluation of patient and setting characteristics should guide the decision on how to start CPR in such cases.