Percutaneous Tracheostomy With a Demistifier Canopy in the COVID-19 Era: A Safe Technique in the Intensive Care Unit.

BACKGROUND: Endoscopic percutaneous tracheostomy (PT) is a safe technique that is performed frequently by otolaryngologists and intensivists. New challenges have been identified in order to maintain the safety of this procedure during the COVID-19 pandemic. A novel approach, using a modified demistifier canopy, was developed during the first wave of the pandemic and implemented for 17 consecutive percutaneous tracheostomies in order to enhance procedural safety. METHODS: A protocol was developed after performing a literature review of tracheostomy in COVID-19 patients. A multidisciplinary tracheostomy team was established, including the departments of otolaryngology, critical care, and respiratory therapy. Simulation was performed prior to each PT, and postoperative debriefings were done. RESULTS: A protocol and technical description of PT using a modified demistifier canopy covering was written and video documented. Data were collected on 17 patients who underwent this procedure safely in our tertiary care hospital. There were no procedure-related complications, and no evidence of COVID-19 transmission to any member of the health care team during the study period. CONCLUSION: As patients continue to recover from COVID-19, their need for tracheostomy will increase. The technique described provides a safe, multidisciplinary method of performing PT in COVID-19 patients.

Factors associated with bicycle helmet use and proper fit: a cross-sectional survey of Montreal cyclists during the COVID-19 pandemic.

OBJECTIVES: With increased bicycle use during the COVID-19 pandemic and growing availability of bicycle-sharing programs in Montreal, we hypothesize helmet use has decreased. The aim of this study was to evaluate helmet use and proper fit among Montreal cyclists during the pandemic relative to historical data. METHODS: Nine observers collected data on bike type, gender, helmet use, and ethnicity using the iHelmet© app at 18 locations across the island of Montreal from June to September 2021. Proper helmet wear was assessed at one busy location. Multiple logistic regression was used to identify factors associated with helmet wear and results were compared to a historical study. RESULTS: Of the 2200 cyclists observed, 1109 (50.4%) wore a helmet. Males (OR = 0.78, 95%CI = 0.65-0.95), young adults (OR = 0.65, 95%CI = 0.51-0.84), visible minorities (OR = 0.38, 95%CI = 0.28-0.53), and bike-share users (OR = 0.21, 95%CI = 0.15-0.28) were less likely to be wearing a helmet, whereas children (OR = 3.92, 95%CI = 2.17-7.08) and cyclists using racing bicycles (OR = 3.84, 95%CI = 2.62-5.62) were more likely to be wearing a helmet. The majority (139/213; 65.3%) of assessed cyclists wore properly fitting helmets. Children had the lowest odds of having a properly fitted helmet (OR = 0.13, 95%CI = 0.04-0.41). Compared to 2011, helmet use during the pandemic increased significantly (1109/2200 (50.4%) vs. 2192/4789 (45.8%); p = 0.032). CONCLUSION: Helmet use among Montreal cyclists was associated with age, gender, ethnicity, and type of bicycle. Children were least likely to have a properly fitted helmet. The recent increase in popularity of cycling and expansion of bicycle-sharing programs reinforce the need for bicycle helmet awareness initiatives, legislation, and funding prioritization.

RéSUMé: OBJECTIF: Avec la popularité grandissante du vélo durant la pandémie COVID-19 et l'expansion du vélopartage à Montréal, nous croyons que le port du casque a diminué. L'objectif de cette étude était d'évaluer l'utilisation du casque et le port adéquat parmi les cyclistes montréalais et de comparer nos résultats avec des données historiques. MéTHODE: Neuf observateurs, stationnés à 18 emplacements, ont recueilli les informations suivantes en utilisant l'application mobile iHelmet© : type de vélo, sexe, origine ethnique et port du casque. Le port adéquat du casque a été observé à un endroit. L'association de chaque variable avec le port et le port adéquat a été fait par régression multivariable et comparé à des données historiques. RéSULTATS: Des 2 200 cyclistes observés, 1 109 (50,4 %) portaient un casque. Les enfants (OR = 3,92, IC95% = 2,17­7,08) et les cyclistes de performance (OR = 3,84, IC95% = 2,62­5,62) portaient le casque plus fréquemment tandis que les hommes (OR = 0,78, IC95% = 0,65­0,95), les jeunes adultes (OR = 0,65, IC95% = 0,51­0,84), les minorités visibles (OR = 0,38, IC95% = 0,28­0,53), et les utilisateurs de vélopartage (OR = 0,21, IC95% = 0,15­0,28) le portaient moins. La majorité (139/213; 65,3 %) des casques étaient portés adéquatement. Les enfants étaient plus à risque de porter un casque mal ajusté (OR = 0,13, IC95% = 0,04­0,41). L'utilisation d'un casque chez les cyclistes montréalais a augmenté significativement depuis 2011 (1 109/2 200 (50,4 %) c. 2 192/4 789 (45,8 %); p = 0,032). CONCLUSION: Le port du casque à vélo à Montréal est associé à l'âge, le sexe, l'origine ethnique et le type de vélo. Les enfants sont plus à risque de mal porter un casque. Des stratégies de promotion ainsi que la législation peuvent favoriser des comportements sécuritaires à vélo.

Cost-effectiveness of remdesivir plus usual care versus usual care alone for hospitalized patients with COVID-19: an economic evaluation as part of the Canadian Treatments for COVID-19 (CATCO) randomized clinical trial.

BACKGROUND: The role of remdesivir in the treatment of hospitalized patients with COVID-19 remains ill-defined. We conducted a cost-effectiveness analysis alongside the Canadian Treatments for COVID-19 (CATCO) open-label, randomized clinical trial evaluating remdesivir. METHODS: Patients with COVID-19 in Canadian hospitals from Aug. 14, 2020, to Apr. 1, 2021, were randomly assigned to receive remdesivir plus usual care versus usual care alone. Taking a public health care payer's perspective, we collected in-hospital outcomes and health care resource utilization alongside estimated unit costs in 2020 Canadian dollars over a time horizon from randomization to hospital discharge or death. Data from 1281 adults admitted to 52 hospitals in 6 Canadian provinces were analyzed. RESULTS: The total mean cost per patient was $37 918 (standard deviation [SD] $42 413; 95% confidence interval [CI] $34 617 to $41 220) for patients randomly assigned to the remdesivir group and $38 026 (SD $46 021; 95% CI $34 480 to $41 573) for patients receiving usual care (incremental cost -$108 [95% CI -$4953 to $4737], p > 0.9). The difference in proportions of in-hospital deaths between remdesivir and usual care groups was -3.9% (18.7% v. 22.6%, 95% CI -8.3% to 1.0%, p = 0.09). The difference in proportions of incident invasive mechanical ventilation events between groups was -7.0% (8.0% v. 15.0%, 95% CI -10.6% to -3.4%, p = 0.006), whereas the difference in proportions of total mechanical ventilation events between groups was -5.7% (16.4% v. 22.1%, 95% CI -10.0% to -1.4%, p = 0.01). Remdesivir was the dominant intervention (but only marginally less costly, with mildly lower mortality) with an incalculable incremental cost effectiveness ratio; we report results of incremental costs and incremental effects separately. For willingness-to-pay thresholds of $0, $20 000, $50 000 and $100 000 per death averted, a strategy using remdesivir was cost-effective in 60%, 67%, 74% and 79% of simulations, respectively. The remdesivir costs were the fifth highest cost driver, offset by shorter lengths of stay and less mechanical ventilation. INTERPRETATION: From a health care payer perspective, treating patients hospitalized with COVID-19 with remdesivir and usual care appears to be preferrable to treating with usual care alone, albeit with marginal incremental cost and small clinical effects. The added cost of remdesivir was offset by shorter lengths of stay in the intensive care unit and less need for ventilation. STUDY REGISTRATION: ClinicalTrials. gov, no. NCT04330690.

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

BACKGROUND: The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems. METHODS: We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation. RESULTS: Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir (n = 634) or standard of care (n = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care (p = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups. INTERPRETATION: Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation. Trial registration: ClinicalTrials.gov, no. NCT04330690.

Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial.

OBJECTIVES: As there is no treatment for COVID-19 with a proven mortality benefit at this moment in the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation, highly demanding and leading to potential staff shortages in ICU. We need to reduce unnecessary exposure of healthcare workers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19. In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19. TRIAL DESIGN: A pilot multicenter prospective crossover noninferiority randomized controlled trial. PARTICIPANTS: All mechanically ventilated patients with COVID-19 admitted to one of the two ICUs, and CPT ordered by the responsible physician. The participants will be recruited from two intensive care units in Canadian Academic Hospitals (one pediatric and one adult ICU). INTERVENTION AND COMPARATOR: We will implement NIOD and CPT alternatingly for 3 h apart over 3 h. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, intermittent positive pressure ventilation, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing positive end-expiratory pressure or changing the nasal mask to total face continuous positive airway pressure) can be provided at the direction of bedside intensivists in charge. MAIN OUTCOMES: The primary outcome measurement is the oxygenation level before and after the procedure (SpO2/FiO2 ratio). For cases with invasive ventilation (i.e., the use of an endotracheal tube to deliver positive pressure) and non-invasive ventilation, we will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, hypoxemia, or unexpected extubation. We will collect the data before, 10 min after, and 30 min after the procedure. RANDOMIZATION: The order of the procedures (i.e., NIOD or CPT) will be randomly allocated using manual generated random numbers for each case. Randomization will be carried out by the independent research assistant in the study coordinating center by using opaque sealed envelopes, assigning an equal number of cases to each intervention arm. Stratification will be applied for age (> 18 years or ≤ 18 years of age) and the study sites. BLINDING (MASKING): No blinding will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): We estimate the necessary sample size as 25 for each arm (total 50 cases), with a power of 0.90 and an alpha of 0.05, with a non-inferiority design. TRIAL STATUS: The protocol version number 1 was approved on 27 March 2020. Currently, recruitment has not yet started, with the start scheduled by the mid-June 2020 and the end anticipated by December 2020. TRIAL REGISTRATION: ClinicalTrials.gov NCT04361435 . Registered on 28 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.