Combined extracorporeal CO2 removal and renal replacement therapy in a pregnant patient with COVID-19: a case report.

Background. Pregnant women are at high risk of Coronavirus disease 2019 (COVID-19) complications, including acute respiratory distress syndrome. Currently, one of the cornerstones in the treatment of this condition is lung-protective ventilation (LPV) with low tidal volumes. However, the occurrence of hypercapnia may limit this ventilatory strategy. So, different extracorporeal CO2 removal (ECCO2R) procedures have been developed. ECCO2R comprises a variety of techniques, including low-flow and high-flow systems, that may be performed with dedicated devices or combined with continuous renal replacement therapy (CRRT). Case description. Here, we report a unique case of a pregnant patient affected by COVID-19 who required extracorporeal support for multiorgan failure. While on LPV, because of the concomitant hypercapnia and acute kidney injury, the patient was treated with an ECCO2R membrane inserted in series after a hemofilter in a CRRT platform. This combined treatment reducing hypercapnia allowed LPV maintenance at the same time while providing kidney replacement and ensuring maternal and fetal hemodynamic stability. Adverse effects consisted of minor bleeding episodes due to the anticoagulation required to maintain the extracorporeal circuit patency. The patient's pulmonary and kidney function progressively recovered, permitting the withdrawal of any extracorporeal treatment. At the 25th gestational week, the patient underwent spontaneous premature vaginal delivery because of placental abruption. She gave birth to an 800-gram female baby, who three days later died because of multiorgan failure related to extreme prematurity. Conclusions. This case supports using ECCO2R-CRRT combined treatment as a suitable approach in the management of complex conditions, such as pregnancy, even in the case of severe COVID-19.

Cost-Effective Solution of Remote Photoplethysmography Capable of Real-Time, Multi-Subject Monitoring with Social Distancing.

Recent advances in remote-photoplethysmography (rPPG) have enabled the measurement of heart rate (HR), oxygen saturation (SpO2), and blood pressure (BP) in a fully contactless manner. These techniques are increasingly applied clinically given a desire to minimize exposure to individuals with infectious symptoms. However, accurate rPPG estimation often leads to heavy loading in computation that either limits its real-time capacity or results in a costly setup. Additionally, acquiring rPPG while maintaining protective distance would require high resolution cameras to ensure adequate pixels coverage for the region of interest, increasing computational burden. Here, we propose a cost-effective platform capable of the real-time, continuous, multi-subject monitoring while maintaining social distancing. The platform is composed of a centralized computing unit and multiple low-cost wireless cameras. We demonstrate that the central computing unit is able to simultaneously handle continuous rPPG monitoring of five subjects with social distancing without compromising the frame rate and rPPG accuracy.

Acceptance of a computer vision facilitated protocol to measure adherence to face mask use: a single-site, observational cohort study among hospital staff.

OBJECTIVES: Mask adherence continues to be a critical public health measure to prevent transmission of aerosol pathogens, such as SARS-CoV-2. We aimed to develop and deploy a computer vision algorithm to provide real-time feedback of mask wearing among staff in a hospital. DESIGN: Single-site, observational cohort study. SETTING: An urban, academic hospital in Boston, Massachusetts, USA. PARTICIPANTS: We enrolled adult hospital staff entering the hospital at a key ingress point. INTERVENTIONS: Consenting participants entering the hospital were invited to experience the computer vision mask detection system. Key aspects of the detection algorithm and feedback were described to participants, who then completed a quantitative assessment to understand their perceptions and acceptance of interacting with the system to detect their mask adherence. OUTCOME MEASURES: Primary outcomes were willingness to interact with the mask system, and the degree of comfort participants felt in interacting with a public facing computer vision mask algorithm. RESULTS: One hundred and eleven participants with mean age 40 (SD15.5) were enrolled in the study. Males (47.7%) and females (52.3%) were equally represented, and the majority identified as white (N=54, 49%). Most participants (N=97, 87.3%) reported acceptance of the system and most participants (N=84, 75.7%) were accepting of deployment of the system to reinforce mask adherence in public places. One third of participants (N=36) felt that a public facing computer vision system would be an intrusion into personal privacy.Public-facing computer vision software to detect and provide feedback around mask adherence may be acceptable in the hospital setting. Similar systems may be considered for deployment in locations where mask adherence is important.

Respirators in Healthcare: Material, Design, Regulatory, Environmental, and Economic Considerations for Clinical Efficacy.

Maintaining an ample supply of personal protective equipment continues to be a challenge for the healthcare industry, especially during emergency situations and times of strain on the supply chain. Most critically, healthcare workers exposed to potential airborne hazards require sufficient respiratory protection. Respirators are the only type of personal protective equipment able to provide adequate respiratory protection. However, their ability to shield hazards depends on design, material, proper fit, and environmental conditions. As a result, not all respirators may be adequate for all scenarios. Additionally, factors including user comfort, ease of use, and cost contribute to respirator effectiveness. Therefore, a careful consideration of these parameters is essential for ensuring respiratory protection for those working in the healthcare industry. Here respirator design and material characteristics are reviewed, as well as properties of airborne hazards and potential filtration mechanisms, regulatory standards of governmental agencies, respirator efficacy in the clinical setting, attitude of healthcare personnel toward respiratory protection, and environmental and economic considerations of respirator manufacturing and distribution.

Impact of COVID-19 Pandemic on In-Hospital Acute Kidney Injury Epidemiology and Outcomes: A Retrospective Cohort Study

BACKGROUND AND AIMS Acute kidney injury (AKI) is a common complication in patients affected by coronavirus disease-19 (COVID-19) and its development is associated with high mortality [1]. However, it is also clear that the COVID-19 pandemic has effects on the management of diseases not directly related to COVID-19 [2]. In this study, we investigated the impact of the COVID-19 pandemic on general intrahospital AKI incidence and outcomes. METHOD We performed a retrospective cohort study comparing data on AKI epidemiology and outcomes of patients hospitalized from January 2016 to December 2019 (pre-COVID-19 period) and from January to December 2020 (COVID-19 period, including both SARS-CoV-2 negative and positive patients). AKI was defined and classified by evaluating the kinetics of intra-hospital creatinine (comparing the peak to the minimum serum creatinine level, considered as the basal value) [3]. The prevalence of chronic kidney disease (CKD) (i.e. eGFR < 60 mL/min) was calculated in patients with previous creatinine values available. Patients with CKD stage 4–5 (i.e. eGFR < 30 mL/min/1.73 m2) and with a length of hospital stay > 30 days were excluded. RESULTS A total of 51 681 patients during the pre-COVID-19 period and 10 ,062 during the COVID-19 period (9026 SARS-CoV-2 negative and 1036 SARS-CoV-2 positive patients) were analysed. Patients admitted in the COVID-19 period were significantly older, with a higher prevalence of males and a reduced prevalence of chronic conditions. In-hospital AKI incidence was 31.7% during the COVID-19 period (30.5% in SARS-CoV-2 negative patients and 42.2% in SARS-CoV-2 positive ones) as compared with 25.9% during the pre-COVID-19 period (P < .0001) (Fig. 1). Similarly, the COVID-19 period showed an increase in AKI stage 2–3 incidence both for AKI on CKD and for ‘de novo AKI’. In multivariate analysis, demographic characteristics, length of hospital stay, ICU admission, main comorbidities, basal sCr, admission period (pre-COVID-19 or COVID-19) and SARS-CoV-2 infection were significantly associated with the risk of AKI. In particular, the admission in the COVID-19 period increased the risk of AKI [OR 1.18, 95% confidence interval (95% CI) 1.12–2.25] regardless of SARS-CoV-2 infection. Moreover, we found that in the COVID-19 period, there was an increased number of patients admitted to ICU, accompanied by a significant increase in the length of hospital stay and intrahospital mortality. In the multivariate analysis, development of AKI, admission in the COVID-19 period and active SARS-CoV-2 infection remained significantly and independently associated with mortality risk (Fig. 2).Figure 1: Incidence and staging of in-hospital AKI. Comparison of AKI incidence and stages between patients hospitalized in the pre-COVID-19 period (2016–2019) versus COVID-19 period (2020). *P < 0.0001 versus pre-COVID-19;§ P < .0001 versus pre-COVID-19 and SARS-CoV-2 negative.Figure 2: Cox regression analyses for intra-hospital mortality in hospitalized patients between 2016 and 2020. CONCLUSION Overall, we found that AKI was more common and severe in the COVID-19 period, regardless of SARS-CoV-2 infection, when compared with patients admitted to the same hospital during the four years before the pandemic. So, we provide evidence that the COVID-19 pandemic has changed general in-hospital AKI epidemiology. These findings call attention to the need to adapt the resources dedicated to the prevention and management of the intra-hospital AKI in response to health emergencies.

Clinical Characteristics, Management and Outcomes of Critically ill COVID-19 Patients Undergoing CRRT: Comparison Between the First Two Pandemic Waves

BACKGROUND AND AIMS Acute kidney injury (AKI) is a common complication of coronavirus disease-19 (COVID-19), which, particularly in critically ill patients requiring continuous renal replacement therapy (CRRT), is associated with an elevated mortality risk [1, 2]. However, knowledge about COVID-19 pathogenesis and management is evolving, and clinical practice is changing rapidly. Here, we evaluated if this process had an impact on the management and outcome of AKI patients. METHODS We performed a retrospective observational study on critically ill adult COVID-19 patients who received CRRT in the intensive care unit (ICU) during the first two pandemic waves before the availability of COVID-19 vaccines: the first one from March to August 2020 (first) and the second one (second) from September to December 2020. RESULTS Overall, we considered 63 patients, aged 65 (60–69) years, 76.2% males. The main comorbidities were diabetes (DM), cardiovascular disease (CVD) and chronic kidney disease (CKD). Among them, 28 (44%) were in the first group and 35 (66%) in the second group. There were no significant differences in general characteristics, such as in comorbidities, except for a higher prevalence of CVD in the first group (Fig. 1). Lab examinations at ICU admission, including serum creatinine level (sCr), were not different between the two groups. While all patients required respiratory support, non-invasive ventilation was more prevalent in the second wave. Notably, during this period, decapneization combined with CRRT was introduced. Regarding drugs, we found that in the second group, hydroxychloroquine was abandoned, tocilizumab use was reduced and heparin administration significantly increased. The AKI time course was similar between the patients of the two waves (Fig. 2). There were no significant differences in CRRT techniques. However, in the second, the use of additional CRRT-devices, in particular adsorption-based filters, significantly increased. In most cases, citrate anticoagulation was used in both groups. Looking at the outcomes, we found no significant difference between the two waves. Indeed, 17 (60.2%) and 22 (62.8%) patients died in the ICU in the first and second groups, respectively. The length of ICU hospitalization, days on CRRT, invasive ventilation and DM were significantly related to overall mortality;time of ICU hospitalization was the only remaining significant at multivariate Cox regression. Overall, 21 (33%) patients survived hospitalization. At the 6 months after the discharge, 3 of them died, 3 were on HD and 15 were dialysis-free, even if 6 of them presented CKD.FIGURE 1: Clinical characteristics and ICU management of critically ill COVID-19 patients undergoing CRRT.FIGURE 2: Kidney function and management of critically ill COVID-19 patients undergoing CRRT. CONCLUSION Our data confirm the high complexity and mortality of COVID-19 patients undergoing CRRT. Comparing the first two pandemic waves, we found that the patients also presented similar characteristics in terms of renal function and AKI time course. Regarding treatments, we observed some significant modifications in the management of ventilation, drug administration and dialysis membranes, mainly because of the results of ongoing clinical trials. However, these changes did not impact patients’ outcomes. These data support the view that only game-change strategies, such as vaccination or infection-specific drugs, may impact the presentation and outcome of COVID-19 patients undergoing CRRT. Finally, patients surviving this condition deserve special attention in the follow-up.

Changes of Acute Kidney Injury Epidemiology during the COVID-19 Pandemic: A Retrospective Cohort Study.

To evaluate the impact of the Coronavirus Disease-19 (COVID-19) pandemic on the epidemiology of acute kidney injury (AKI) in hospitalized patients, we performed a retrospective cohort study comparing data of patients hospitalized from January 2016 to December 2019 (pre-COVID-19 period) and from January to December 2020 (COVID-19 period, including both severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative and positive patients). AKI was classified by evaluating the kinetics of creatinine levels. A total of 51,681 patients during the pre-COVID-19 period and 10,062 during the COVID-19 period (9026 SARS-CoV-2-negative and 1036 SARS-CoV-2-positive) were analyzed. Patients admitted in the COVID-19 period were significantly older, with a higher prevalence of males. In-hospital AKI incidence was 31.7% during the COVID-19 period (30.5% in SARS-CoV-2-negative patients and 42.2% in SARS-CoV-2-positive ones) as compared to 25.9% during the pre-COVID-19 period (p < 0.0001). In the multivariate analysis, AKI development was independently associated with both SARS-CoV-2 infection and admission period. Moreover, evaluating the pre-admission estimated glomerular filtration rate (eGFR) we found that during the COVID-19 period, there was an increase in AKI stage 2-3 incidence both in patients with pre-admission eGFR < 60 mL/min/1.73 m2 and in those with eGFR ≥ 60 mL/min/1.73 m2 ("de novo" AKI). Similarly, clinical outcomes evaluated as intensive care unit admission, length of hospital stay, and mortality were significantly worse in patients admitted in the COVID-19 period. Additionally, in this case, the mortality was independently correlated with the admission during the COVID-19 period and SARS-CoV-2 infection. In conclusion, we found that during the COVID-19 pandemic, in-hospital AKI epidemiology has changed, not only for patients affected by COVID-19. These modifications underline the necessity to rethink AKI management during health emergencies.

Mobile Robotic Platform for Contactless Vital Sign Monitoring.

The COVID-19 pandemic has accelerated methods to facilitate contactless evaluation of patients in hospital settings. By minimizing in-person contact with individuals who may have COVID-19, healthcare workers can prevent disease transmission and conserve personal protective equipment. Obtaining vital signs is a ubiquitous task that is commonly done in person by healthcare workers. To eliminate the need for in-person contact for vital sign measurement in the hospital setting, we developed Dr. Spot, a mobile quadruped robotic system. The system includes IR and RGB cameras for vital sign monitoring and a tablet computer for face-to-face medical interviewing. Dr. Spot is teleoperated by trained clinical staff to simultaneously measure the skin temperature, respiratory rate, and heart rate while maintaining social distancing from patients and without removing their mask. To enable accurate, contactless measurements on a mobile system without a static black body as reference, we propose novel methods for skin temperature compensation and respiratory rate measurement at various distances between the subject and the cameras, up to 5 m. Without compensation, the skin temperature MAE is 1.3°C. Using the proposed compensation method, the skin temperature MAE is reduced to 0.3°C. The respiratory rate method can provide continuous monitoring with a MAE of 1.6 BPM in 30 s or rapid screening with a MAE of 2.1 BPM in 10 s. For the heart rate estimation, our system is able to achieve a MAE less than 8 BPM in 10 s measured in arbitrary indoor light conditions at any distance below 2 m.

Patient and Health Care Worker Perceptions of Communication and Ability to Identify Emotion When Wearing Standard and Transparent Masks.

Importance: Adoption of mask wearing in response to the COVID-19 pandemic alters daily communication. Objective: To assess communication barriers associated with mask wearing in patient-clinician interactions and individuals who are deaf and hard of hearing. Design, Setting, and Participants: This pilot cross-sectional survey study included the general population, health care workers, and health care workers who are deaf or hard of hearing in the United States. Volunteers were sampled via an opt-in survey panel and nonrandomized convenience sampling. The general population survey was conducted between January 5 and January 8, 2021. The health care worker surveys were conducted between December 3, 2020, and January 3, 2021. Respondents viewed 2 short videos of a study author wearing both a standard and transparent N95 mask and answered questions regarding mask use, communication, preference, and fit. Surveys took 15 to 20 minutes to complete. Main Outcomes and Measures: Participants' perceptions were assessed surrounding the use of both mask types related to communication and the ability to express emotions. Results: The national survey consisted of 1000 participants (mean [SD] age, 48.7 [18.5] years; 496 [49.6%] women) with a response rate of 92.25%. The survey of general health care workers consisted of 123 participants (mean [SD] age, 49.5 [9.0] years; 84 [68.3%] women), with a response rate of 11.14%. The survey of health care workers who are deaf or hard of hearing consisted of 45 participants (mean [SD] age, 54.5 [9.0] years; 30 [66.7%] women) with a response rate of 23.95%. After viewing a video demonstrating a study author wearing a transparent N95 mask, 781 (78.1%) in the general population, 109 general health care workers (88.6%), and 38 health care workers who are deaf or hard of hearing (84.4%) were able to identify the emotion being expressed, in contrast with 201 (20.1%), 25 (20.5%), and 11 (24.4%) for the standard opaque N95 mask. In the general population, 450 (45.0%) felt positively about interacting with a health care worker wearing a transparent mask; 76 general health care workers (61.8%) and 37 health care workers who are deaf or hard of hearing (82.2%) felt positively about wearing a transparent mask to communicate with patients. Conclusions and Relevance: The findings of this study suggest that transparent masks could help improve communication during the COVID-19 pandemic, particularly for individuals who are deaf and hard of hearing.

Thinking green: modelling respirator reuse strategies to reduce cost and waste.

OBJECTIVES: To compare the impact of respirator extended use and reuse strategies with regard to cost and sustainability during the COVID-19 pandemic. DESIGN: Cost analysis. SETTING: USA. PARTICIPANTS: All healthcare workers within the USA. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A model was developed to estimate usage, costs and waste incurred by several respirator usage strategies over the first 6 months of the pandemic in the USA. This model assumed universal masking of all healthcare workers. Estimates were taken from the literature, government databases and commercially available data from approved vendors. RESULTS: A new N95 respirator per patient encounter would require 7.41 billion respirators, cost $6.38 billion and generate 84.0 million kg of waste in the USA over 6 months. One respirator per day per healthcare worker would require 3.29 billion respirators, cost $2.83 billion and generate 37.22 million kg of waste. Decontamination by ultraviolet germicidal irradiation would require 1.64 billion respirators, cost $1.41 billion and accumulate 18.61 million kg of waste. H2O2 vapour decontamination would require 1.15 billion respirators, cost $1.65 billion and produce 13.03 million kg of waste. One reusable respirator with daily disposable filters would require 18 million respirators, cost $1.24 billion and generate 15.73 million kg of waste. Pairing a reusable respirator with H2O2 vapour-decontaminated filters would reduce cost to $831 million and generate 1.58 million kg of waste. The use of one surgical mask per healthcare worker per day would require 3.29 billion masks, cost $460 million and generate 27.92 million kg of waste. CONCLUSIONS: Decontamination and reusable respirator-based strategies decreased the number of respirators used, costs and waste generated compared with single-use or daily extended-use of disposable respirators. Future development of low-cost,simple technologies to enable respirator and/or filter decontamination is needed to further minimise the economic and environmental costs of masks.

Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation.

Importance: Before the widespread implementation of robotic systems to provide patient care during the COVID-19 pandemic occurs, it is important to understand the acceptability of these systems among patients and the economic consequences associated with the adoption of robotics in health care settings. Objective: To assess the acceptability and feasibility of using a mobile robotic system to facilitate health care tasks. Design, Setting, and Participants: This study included 2 components: a national survey to examine the acceptability of using robotic systems to perform health care tasks in a hospital setting and a single-site cohort study of patient experiences and satisfaction with the use of a mobile robotic system to facilitate triage and telehealth tasks in the emergency department (ED). The national survey comprised individuals living in the US who participated in a sampling-based survey via an online analytic platform. Participants completed the national survey between August 18 and August 21, 2020. The single-site cohort study included patients living in the US who presented to the ED of a large urban academic hospital providing quaternary care in Boston, Massachusetts between April and August 2020. All data were analyzed from August to October 2020. Exposures: Participants in the national survey completed an online survey to measure the acceptability of using a mobile robotic system to perform health care tasks (facilitating telehealth interviews, acquiring vital signs, obtaining nasal or oral swabs, placing an intravenous catheter, performing phlebotomy, and turning a patient in bed) in a hospital setting in the contexts of general interaction and interaction during the COVID-19 pandemic. Patients in the cohort study were exposed to a mobile robotic system, which was controlled by an ED clinician and used to facilitate a triage interview. After exposure, patients completed an assessment to measure their satisfaction with the robotic system. Main Outcomes and Measures: Acceptability of the use of a mobile robotic system to facilitate health care tasks in a hospital setting (national survey) and feasibility and patient satisfaction regarding the use of a mobile robotic system in the ED (cohort study). Results: For the national survey, 1154 participants completed all acceptability questions, representing a participation rate of 35%. After sample matching, a nationally representative sample of 1000 participants (mean [SD] age, 48.7 [17.0] years; 535 women [53.5%]) was included in the analysis. With regard to the usefulness of a robotic system to perform specific health care tasks, the response of "somewhat useful" was selected by 373 participants (37.3%) for facilitating telehealth interviews, 350 participants (35.0%) for acquiring vital signs, 307 participants (30.7%) for obtaining nasal or oral swabs, 228 participants (22.8%) for placing an intravenous catheter, 249 participants (24.9%) for performing phlebotomy, and 371 participants (37.1%) for turning a patient in bed. The response of "extremely useful" was selected by 287 participants (28.7%) for facilitating telehealth interviews, 413 participants (41.3%) for acquiring vital signs, 192 participants (19.2%) for obtaining nasal or oral swabs, 159 participants (15.9%) for placing an intravenous catheter, 167 participants (16.7%) for performing phlebotomy, and 371 participants (37.1%) for turning a patient in bed. In the context of the COVID-19 pandemic, the median number of individuals who perceived the application of robotic systems to be acceptable for completing telehealth interviews, obtaining nasal and oral swabs, placing an intravenous catheter, and performing phlebotomy increased. For the ED cohort study, 51 individuals were invited to participate, and 41 participants (80.4%) enrolled. One participant was unable to complete the study procedures because of a signaling malfunction in the robotic system. Forty patients (mean [SD] age, 45.8 [2.7] years; 29 women [72.5%]) completed the mobile robotic system-facilitated triage interview, and 37 patients (92.5%) reported that the interaction was satisfactory. A total of 33 participants (82.5%) reported that their experience of receiving an interview facilitated by a mobile robotic system was as satisfactory as receiving an in-person interview from a clinician. Conclusions and Relevance: In this study, a mobile robotic system was perceived to be acceptable for use in a broad set of health care tasks among survey respondents across the US. The use of a mobile robotic system enabled the facilitation of contactless triage interviews of patients in the ED and was considered acceptable among participants. Most patients in the ED rated the quality of mobile robotic system-facilitated interaction to be equivalent to in-person interaction with a clinician.

Prospective Evaluation of the Transparent, Elastomeric, Adaptable, Long-Lasting (TEAL) Respirator.

N95 filtering facepiece respirators (FFR) and surgical masks are essential in reducing airborne disease transmission, particularly during the COVID-19 pandemic. However, currently available FFR's and masks have major limitations, including masking facial features, waste, and integrity after decontamination. In a multi-institutional trial, we evaluated a transparent, elastomeric, adaptable, long-lasting (TEAL) respirator to evaluate success of qualitative fit test with user experience and biometric evaluation of temperature, respiratory rate, and fit of respirator using a novel sensor. There was a 100% successful fit test among participants, with feedback demonstrating excellent or good fit (90% of participants), breathability (77.5%), and filter exchange (95%). Biometric testing demonstrated significant differences between exhalation and inhalation pressures among a poorly fitting respirator, well-fitting respirator, and the occlusion of one filter of the respirator. We have designed and evaluated a transparent elastomeric respirator and a novel biometric feedback system that could be implemented in the hospital setting.

A rapidly deployable individualized system for augmenting ventilator capacity

Strategies to split ventilators to support multiple patients requiring ventilatory support have been proposed and used in emergency cases in which shortages of ventilators cannot otherwise be remedied by production or procurement strategies. However, the current approaches to ventilator sharing lack the ability to individualize ventilation to each patient, measure pulmonary mechanics, and accommodate rebalancing of the airflow when one patient improves or deteriorates, posing safety concerns to patients. Potential cross-contamination, lack of alarms, insufficient monitoring, and inability to adapt to sudden changes in patient status have prevented widespread acceptance of ventilator sharing. We have developed an individualized system for augmenting ventilator efficacy (iSAVE) as a rapidly deployable platform that uses a single ventilator to simultaneously and more safely support two individuals. The iSAVE enables individual-specific volume and pressure control and the rebalancing of ventilation in response to improvement or deterioration in an individual's respiratory status. The iSAVE incorporates mechanisms to measure pulmonary mechanics, mitigate cross-contamination and backflow, and accommodate sudden flow changes due to individual interdependencies within the respiratory circuit. We demonstrate these capacities through validation using closed- and open-circuit ventilators on linear test lungs. We show that the iSAVE can temporarily ventilate two pigs on one ventilator as efficaciously as each pig on its own ventilator. By leveraging off-the-shelf medical components, the iSAVE could rapidly expand the ventilation capacity of health care facilities during emergency situations such as pandemics.

Injection Molded Autoclavable, Scalable, Conformable (iMASC) system for aerosol-based protection: a prospective single-arm feasibility study.

OBJECTIVE: To develop and test a new reusable, sterilisable N95 filtering facepiece respirator (FFR)-comparable face mask, known as the Injection Molded Autoclavable, Scalable, Conformable (iMASC) system, given the dire need for personal protective equipment within healthcare settings during the COVID-19 pandemic. DESIGN: Single-arm feasibility study. SETTING: Emergency department and outpatient oncology clinic. PARTICIPANTS: Healthcare workers who have previously undergone N95 fit testing. INTERVENTIONS: Fit testing of new iMASC system. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome is success of fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method, and secondary outcomes are user experience with fit, breathability and filter replacement. RESULTS: Twenty-four subjects were recruited to undergo fit testing, and the average age of subjects was 41 years (range of 21-65 years) with an average body mass index of 26.5 kg/m2. The breakdown of participants by profession was 46% nurses (n=11), 21% attending physicians (n=5), 21% resident physicians (n=5) and 12% technicians (n=3). Of these participants, four did not perform the fit testing due to the inability to detect saccharin solution on premask placement sensitivity test, lack of time and inability to place mask over hair. All participants (n=20) who performed the fit test were successfully fitted for the iMASC system using an OSHA-approved testing method. User experience with the iMASC system, as evaluated using a Likert scale with a score of 1 indicating excellent and a score of 5 indicating very poor, demonstrated an average fit score of 1.75, breathability of 1.6, and ease of replacing the filter on the mask was scored on average as 2.05. CONCLUSIONS: The iMASC system was shown to successfully fit multiple different face sizes and shapes using an OSHA-approved testing method. These data support further certification testing needed for use in the healthcare setting.