[Dooring Bicycle Accidents with Severe Injury Patterns: 10-Year Study of a Level 1 Trauma Center]. / Dooring-Fahrradunfälle mit schweren Verletzungsmustern: 10-Jahres-Studie eines Level-1-Traumazentrums.

Dooring Bicycle Accidents with Severe Injury Patterns: 10-Year Study of a Level 1 Trauma Center Abstract. Studies in Switzerland, Germany and Austria have shown that, contrary to popular belief, dooring accidents are among the most common bicycle accidents. The resulting injuries are often serious and often lead to hospital admission. All dooring accidents of the Inselspital Emergency Department in Bern between 2012 and 2021 were identified and evaluated retrospectively. The data were generated from the database of the management system (Ecare) of the University Hospital Bern by means of a search query with the German keywords: "Autotüre", "Autotuere", "Dooring" and were anonymised. Most patients were female and on average 34 years old; most injuries occurred to the head and the extremities. Treatment was mostly done on an outpatient basis. The ISS (Injury Severity Score) was an average of 3.5. One of the patients needed emergency surgery. This is the first Swiss study to systematically record and evaluate dooring accidents. Since cycling is a trend, especially in urban areas, and consequently the number of cyclists is constantly increasing, it can be assumed that the number of dooring injuries will also increase and corresponding prevention measures will have to be taken. The current COVID-19 pandemic tends to aggravate the problem, as in the context of infection control the number of cyclists and, consequently, accidents is increasing, especially in urban areas, in the context of infection control. This said, it is crucial to gain more information about the time slots of the accidents and the casualties through appropriate studies in order to take adequate preventive and protective measures.

Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial.

PURPOSE: To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. METHODS: This is a pre-planned follow-up study of the Helmet-COVID trial. In this multicenter, randomized clinical trial, adults with acute hypoxemic respiratory failure (n = 320) due to coronavirus disease 2019 (COVID-19) were randomized to receive helmet noninvasive ventilation or usual respiratory support. The modified intention-to-treat population consisted of all enrolled patients except three who were lost at follow-up. The study outcomes were 180-day mortality, EuroQoL (EQ)-5D-5L index values, and EQ-visual analog scale (EQ-VAS). In the modified intention-to-treat analysis, non-survivors were assigned a value of 0 for EQ-5D-5L and EQ-VAS. RESULTS: Within 180 days, 63/159 patients (39.6%) died in the helmet noninvasive ventilation group compared to 65/158 patients (41.1%) in the usual respiratory support group (risk difference - 1.5% (95% confidence interval [CI] - 12.3, 9.3, p = 0.78). In the modified intention-to-treat analysis, patients in the helmet noninvasive ventilation and the usual respiratory support groups did not differ in EQ-5D-5L index values (median 0.68 [IQR 0.00, 1.00], compared to 0.67 [IQR 0.00, 1.00], median difference 0.00 [95% CI - 0.32, 0.32; p = 0.91]) or EQ-VAS scores (median 70 [IQR 0, 93], compared to 70 [IQR 0, 90], median difference 0.00 (95% CI - 31.92, 31.92; p = 0.55). CONCLUSIONS: Helmet noninvasive ventilation did not reduce 180-day mortality or improve HRQoL compared to usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

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.

Pediatric all-terrain vehicle (ATV) related head injury rates and patterns: A 10-year nationwide analysis.

INTRODUCTION: The use of all-terrain vehicles (ATVs) carries significant risk of permanent injury and death, disproportionately affecting children. These injuries commonly affect the head and are especially severe among children as they are often unhelmeted and more likely than adults to experience rollover injuries. Many studies examining patients with ATV-related injuries are single-center cohort studies, with few focusing specifically on head injuries. In the present study, we aimed to characterize the annual incidence of ATV-related head injuries between 2012 and 2021, classify and compare head injury types, and identify descriptive characteristics of ATV-related head injury victims. METHODS: Using the US Consumer Product Safety Commission's National Electronic Injury Surveillance System (NEISS) database, we queried all head injuries associated with operating or riding an ATV in children under 18 years-old from over 100 emergency departments (EDs). Patient information regarding age, race, sex, location of incident, diagnoses, and sequelae were analyzed. We also collected the estimated number of ATV-related head injuries from all US EDs using the NEISS algorithm provided by the database. RESULTS: Using the NEISS algorithm we identified 67,957 (95% CI: 43,608 - 92,305) total pediatric ATV-related head injuries between 2012 and 2021. The annual incidence of ATV-related head injury was similar throughout this study period except for a 20% increase during the COVID-19 pandemic period of 2019-2021 (2019: 6382 injuries, 2020: 6757 injuries, 2021: 7600 injuries). A subset of 1890 cases from approximately 100 EDs were then analyzed. Unspecified closed head injuries were the prevailing type of injury (38%, 900/1890), followed by concussions (27%, 510/1890). More severe injuries included intracranial hemorrhages in 91 children (3.8%, 91/1890). Injuries of all types were predominantly seen in 14-17 year-old's (780/1890, 41%) and in males (64.1%, 1211/1890). In addition, ATV-associated injuries were significantly more common in those coded as white (58.0%, 1096/1890) than any other racial group. ATV-associated accidents among children younger than 9 more commonly occurred at the home compared to accidents involving children older than 9 (57% vs. 32%, p < 0.0001). CONCLUSION: ATV-related head injuries cause a significant annual burden among children, with growing incidence in recent years. Further research may wish to explore potential benefits of helmet use and supervision of younger children in possible prevention of these accidents and their associated economic and non-economic costs.

Use of Micrococcus luteus to assess the quality of protection of respiratory organs using the pneumatic helmet with positive airflow.

In order to effectively protect from dangerous infectious agents, as well as coronavirus, the scientists of I. Horbachevsky Ternopil national medical university (Ukraine) developed a unique prototype of a mobile respiratory protection system with positive airflow - pneumatic helmet. AIM: To evaluate the bacterial permeability of the proposed concept model of the pneumohelmet in full and partial configuration. MATERIALS AND METHODS: With a generating device (compressor inhaler) an aerosol is created from bacterial suspension, which is directed to the inlet of the personal protective respiratory equipment. The outlet is directed at a Petri dish with meat-peptone broth. Evaluation of bacterial contamination is performed by calculating the colony-forming units by multiplying the indicator by the degree of dilution. The study is repeated with a partial configuration of the pneumatic helmet - the presence of only external, only internal filter or not using any filter components. RESULTS: The growth of Micrococcus luteus colonies on the placed nutrient medium when using the proposed conceptual model of the pneumatic helmet in full configuration was not obtained. Removal of the inner filter did not lead to a violation of the effectiveness of antibacterial protection, as bacteria were detected only on the outer side of filter No.2. The use of a conceptual model without filters made it possible to detect colonies of Micrococcus luteus on the medium and components of the device with the calculation of colony forming units in 3- and 4-fold dilutions. During 24 hours of operation, the bacterial load on the surface of the external filter increased significantly. However, no signs of malfunction of the pneumatic helmet were detected. CONCLUSIONS: The given results confirm the ability of the pneumatic helmet to counteract the penetration of bacteria from the environment during 6, 12, 24 hours of continuous operation. The protection was preserved even with partial configuration, which indicates the presence of a margin of reliability of this system.

National incidence and trends of bicycle injury.

Bicycle utilization continues to increase annually, and this trend was recently accelerated by the coronavirus disease of 2019 pandemic. There is limited epidemiologic data, however, regarding the prevalence and nature of bicycle-related injuries. Therefore, the purpose of this study is to characterize trends in bicycle-related injuries. The National Electronic Injury Surveillance System was queried for bicycle-related injuries from 2012 to 2021. Patient demographic and injury data were collected and analyzed to describe trends in incidence, patient demographics, and injury patterns associated with an emergency department encounter for a bicycle-related injury. There were an estimated 4,666,491 (95% confidence interval: 4,661,472-4,671,510) bicycle-related injuries from 2012 to 2021. The incidence of these injuries has significantly decreased over time (R = -0.983, R2 = 0.967, p < 0.001). However, the rate of injury in elderly patients increased over time. Injuries occurred most often during summer months (36%) and on weekend days (31.9%). Males and younger patients were more commonly injured. Head injuries were the most commonly affected body part among all age groups. Fractures were the most common injury type overall. Upper extremity injuries were more common than the lower extremity. Despite increased public bicycle utilization, there is a significant downtrend in bicycle-related injuries over the last decade. Injuries among elderly patients are becoming more common, who demonstrate a high rate of fracture and head injury. Fractures and head injuries were the most common injuries among all age groups, highlighting the importance of bicycle safety initiatives and helmet-wearing regardless of age.

Hypopharynx, oropharynx morphology and histology in severe Coronavirus 2 patients treated by noninvasive ventilation: comparison between full-face mask and helmet strategies.

BACKGROUND: Non-invasive ventilation may alter the morphology and histology of the upper airway mucosa. This study aimed to investigate the alterations of hypopharynx and oropharynx mucosa, identified during oro-tracheal intubation procedure via video-assisted laryngoscopy, in severe acute respiratory syndrome Coronavirus 2 related, treated by non-invasive ventilation via full-face mask or helmet. METHODS: Data of patients affected by Coronavirus 2 admitted to COVID Hospital of L'Aquila (Italy), presenting hypopharynx and oropharynx morphology alterations, requiring oro-tracheal intubation for invasive ventilation and initially treated with non-invasive ventilation were included in the study. The study aimed to investigate the upper airway mucosa alterations using oropharyngeal and hypopharyngeal images and biopsies taken during video-assisted-laryngoscopy. Data from the hypopharynx and oropharynx morphology and histology alterations between non-invasive ventilation via a full-face mask or helmet used during hospitalization were compared. RESULTS: From 220 data recorded, 60 patients were included in the study and classified into non-invasive ventilation full-face mask group (30/60) and via helmet group. Comparing data between groups, significant differences were found with respect to hyperemia (77% vs. 20%), laryngeal bleeding ulcerations (87% vs. 13%), and vocal cord edema with >50% narrowing of the tracheal lumen (73% vs. 7%), respectively. The histology examination revealed fibrin-necrotic exudate with extensive necrotic degenerative changes in the sample tissue of the groups. There were not any differences in the duration time of non-invasive ventilation, time from hospitalization and the start of ventilation between groups. CONCLUSIONS: The data from this research suggested that there were differences in airway mucosa damages among patients treated with a full-face mask or helmet. Further studies should be planned to understand which non-invasive ventilation support may mitigate upper airway mucosa damages when oro-tracheal intubation is requested for invasive respiratory support.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial.

BACKGROUND: Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited. METHODS: In this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk  and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait. DISCUSSION: We developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020.

Saving lives through road safety risk factor interventions: global and national estimates.

Global road mortality is a leading cause of death in many low-income and middle-income countries. Data to support priority setting under current resource constraints are urgently needed to achieve Sustainable Development Goal (SDG) 3.6. This Series paper estimates the potential number of lives saved if each country implemented interventions to address risk factors for road injuries. We did a systematic review of all available evidence-based, preventive interventions for mortality reduction that targeted the four main risk factors for road injuries (ie, speeding, drink driving, helmet use, and use of seatbelt or child restraint). We used literature review variables and considered three key country-level variables (gross domestic product per capita, population density, and government effectiveness) to generate country-specific estimates on the potential annual attributable number of lives that would be saved by interventions focusing on these four risk factors in 185 countries. Our results suggest that the implementation of evidence-based road safety interventions that target the four main road safety risk factors could prevent between 25% and 40% of all fatal road injuries worldwide. Interventions addressing speed could save about 347 258 lives globally per year, and at least 16 304 lives would be saved through drink driving interventions. The implementation of seatbelt interventions could save about 121 083 lives, and 51 698 lives could be saved by helmet interventions. We identify country-specific estimates of the potential number of lives saved that would be attributable to these interventions. Our results show the potential effectiveness of the implementation and scaling of these interventions. This paper presents key evidence for priority setting on road safety interventions and shows a path for reaching SDG 3.6.

DINED (Delivery-related INjuries in the Emergency Department) part 2: A chart review of risk factors and injuries affecting food delivery riders.

OBJECTIVE: This study aimed to examine patterns of injury, the impact of these injuries on patients and identification of potentially modifiable contributing factors through industry regulation reforms and education. METHODS: Food delivery rider (FDR)-related presentations to the Royal Brisbane and Women's Hospital Emergency and Trauma Centre for a year from September 2020 were identified. Data collected included patient and incident demographics: time, type and location of injuries, investigations and care required, length of stay, admission requirements and follow up. RESULTS: The cohort included 81.8% male with a mean age of 25.2 years. Most injuries occurred on the road from a collision with a vehicle. The most common injury was fractures. Incidence increased on weekends and during the evening. More than half the cohort were admitted to hospital. Only 22.7% of patients were eligible for workers compensation and less than half were covered by Medicare. The majority (72.7%) of cases involved non-resident riders from other countries. CONCLUSION: The majority of FDRs presenting with injuries are not Australian citizens and less than half were Medicare eligible potentially contributing to inadequate access to care especially fracture follow up. There were spikes in injuries occurring at night, weekends and during periods of pandemic associated lockdowns demonstrating an increased usage of delivery services during these times. Results highlight injury patterns experienced by delivery riders and potentially modifiable risk factors for this rapidly growing area of employment within the gig economy.

Role of helmet ventilation during the 2019 coronavirus disease pandemic.

Coronavirus disease 2019 (COVID-19) has been declared a pandemic by the World Health Organization; it has affected millions of people and caused hundreds of thousands of deaths. Patients with COVID-19 pneumonia may develop acute hypoxia respiratory failure and require noninvasive respiratory support or invasive respiratory management. Healthcare workers have a high risk of contracting COVID-19 while fitting respiratory devices. Recently, European experts have suggested that the use of helmet continuous positive airway pressure should be the first choice for acute hypoxia respiratory failure caused by COVID-19 because it reduces the spread of the virus in the ambient air. By contrast, in the United States, helmets were restricted for respiratory care before the COVID-19 pandemic until the Food and Drug Administration provided the 'Umbrella Emergency Use Authorization for Ventilators and Ventilator Accessories'. This narrative review provides an evidence-based overview of the use of helmet ventilation for patients with respiratory failure.

The use of a surgical helmet system with a high-efficiency particulate air filter as possible protection equipment during the coronavirus disease 2019 pandemic: a double-blinded randomized control study.

PURPOSE: The rapid spread of coronavirus disease 2019 (COVID-19) has increased the use of personal protective equipment. The purpose of this study was to investigate whether a commercially available sterile surgical helmet system (SSHS) can be considered protective against COVID-19 and therefore safe for use. METHODS: A double-blinded randomized controlled study was performed to investigate the efficacy of the ViVi® SSHS with a high-efficiency particulate air filter called HFD Hood (THI, Total Healthcare Innovation GmbH, Feistritz im Rosental, Austria) to protect against respiratory droplets. Forty recruited participants were divided into two different groups. The SSHS was tested using a validated qualitative test for respirator masks through saccharin or placebo solutions based on random allocation into two cohorts. Saccharin droplets are a validated surrogated marker for any elements of viral size, such as coronaviruses. A positive report of sweet taste after saccharin exposure was suggestive of ViVi® SSHS inefficacy in protection against droplets. RESULTS: One participant out of 21 (4.8%) reported positive for taste within the placebo cohort, while five out of 19 (26.3%) reported positive for taste within the saccharin cohort upon testing. Two out of 21 (9.5%) participants reported positive for taste within the placebo cohort, and two out of 19 (10.5%) reported positive for taste within the saccharin cohort upon retesting. There were no statistically significant differences between the saccharin and placebo groups in either the test or retest measurements (p = 0.085 and p = 1.000, respectively). CONCLUSIONS: This study demonstrates that the ViVi® SSHS equipped with HFD Hood protects against respiratory droplets, increasing protection against several microorganisms, including the virus that causes COVID-19, allowing surgeons to carry out procedures on COVID-positive patients in a more comfortable and safer way.

Surgical helmets can be converted into efficient disinfectable powered air-purifying respirators.

BACKGROUND: Filtering facepiece respirators often fail to provide sufficient protection due to a poor fit. Powered air-purifying respirators (PAPRs) are not designed for healthcare personnel, and are challenging to disinfect. Surgical helmets (SH) are available in many United States hospitals but do not provide respiratory protection. Several modifications to SH have been suggested, but none are sufficiently compliant with safety and efficiency standards. The purpose of this investigation was the development of a filter adaptor, which converts SHs into efficient, safe, and disinfectable PAPRs. METHODS: Four critical features were investigated close to regulatory requirements: total inward leakage of particles, CO2 concentrations, intra-helmet differential pressure, and automated disinfection. RESULTS: The average total inward leakage in the 2 independent tests were 0.005% and 0.01%. CO2 concentrations were lower than in the original SH. The modification generates a positive differential pressure. The filter's performance was not compromised after 50 cycles in a sterilization machine. DISCUSSION: The modified SH provides several hundred times better protection than FFP-3 masks. CONCLUSIONS: Surgical helmets can be modified into safe, efficient, and disinfectable PAPRs, suitable for HCP and the operating room in particular. They can play a role in the preparedness for upcoming events requiring efficient respiratory protection.

Nursing evaluation during treatment with helmet continuous positive airway pressure in patients with respiratory failure due to COVID-19 pneumonia: A case series.

BACKGROUND: During COVID-19 outbreak, with the increasing number of patients presenting with acute respiratory failure, a large use of non invasive positive pressure ventilation was done in the emergency departments and medical wards despite the lack of recommendations. OBJECTIVES: This study describes the clinical characteristics of patients presenting to the hospital with acute respiratory failure due to COVID-19 related pneumonia undergoing treatment with helmet continuous positive airway pressure (CPAP) with a strict nursing evaluation and monitoring. METHODS: A case series study enrolling adult patients admitted to an emergency department of an Italian hospital with acute respiratory failure due to COVID-19 pneumonia from March 18th to April 18th, 2020, was conducted. Only patients who strictly followed a local CPAP protocol were enrolled. RESULTS: A total of 52 patients were included in this study. Thirty-eight patients (73%) were judged eligible for endotracheal intubation (ETI). Eighteen (34.6%) were intubated. Sixteen (30.8%) patients died: seven (38.9%) and nine (26.5%) in the eligible-for-ETI and non eligible-for-ETI group, respectively. The median hospital length of stay was different in the ETI and non-ETI group: 26 days (interquartile range [IQR]: 16-37) vs 15 days [IQR 9-17] (p = 0.005). The median invasive mechanical ventilation time was 11 days [IQR 7-21] with an ICU length of stay of 14.5 days [IQR 10-28]. During the CPAP trial, among patients eligible for ETI variations over time for positive end-expiratory pressure (p = 0.003) and respiratory rate (p = 0.059) were found between intubated and non-intubated patients. CONCLUSIONS: A short closed monitored CPAP trial could be considered for acute respiratory failure due to COVID-19 pneumonia before considering ETI. A progressive positive end-expiratory pressure titration should target reduction in a patient's respiratory rate. More studies are needed to evaluate the efficacy and predictors of failure of CPAP and non-invasive positive pressure ventilation in patients with acute respiratory failure due to COVID-19 pneumonia.

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality. METHODS AND ANALYSIS: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. ETHICS AND DISSEMINATION: Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings. TRIAL REGISTRATION NUMBER: NCT04477668.

Orthopedic Surgical Helmet Systems Significantly Impair Speech Intelligibility.

Surgical suits provide protection to orthopedic surgeons, but the suits and fan noise may interfere with communication between operative team members. The goal of this study was to quantify the fan sound and effect of the suit, fan, and N95 mask. Sound levels were measured using a specialized manikin and evaluated using preferred speech interference levels (PSILs), noise criterion (NC) ratings, and comparison with speech sound levels from the literature. Additionally, sound blocking due to the surgical suit was measured and combined effects of the fan and suit were described using a signal to noise ratio (SNR). The noise with the fan at medium and high speed was louder than average speech and the PSILs at these speeds were significantly higher than with the fan off. The fan NC rating of 50 to 60 exceeded the recommended range of 25 to 30 for operating rooms. The N95 mask, space suit, and distance between speaker and receiver all reduced the sound signal at the receiver's ear, with the worst case being full personal protective equipment on both and speaker distanced from receiver. The estimated SNR for the suit and fan system was negative for many frequency bands used in speech, indicating more noise than signal. Multiple measures indicated that the fan noises were at levels associated with speech interference. This noise combined with sound blocking provided by the suit produced SNRs commonly associated with noisy to very noisy environments. This study suggests the combined effects of the suit, fan, and distance may negatively impact operating room communication. [Orthopedics. 2021;44(4):208-214.].

Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome.

ABSTRACT: The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance. TRIAL REGISTRATION NUMBER: NCT04507802. PROTOCOL VERSION: May 2020.