Rapidly scalable mechanical ventilator for the COVID-19 pandemic.
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ABSTRACT:
SUBMITTER: Kwon AH
PROVIDER: S-EPMC7314912 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
Publications
Rapidly scalable mechanical ventilator for the COVID-19 pandemic.
Kwon Albert H AH Slocum Alexander H AH Varelmann Dirk D Nabzdyk Christoph G S CGS
Intensive care medicine 20200625 8
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Project description: Not available
| S-EPMC8041185 | biostudies-literature
Project description:BackgroundLimited supply of resources during the COVID-19 emergency encouraged the local development of the Masi mechanical ventilator (MV). Despite the efforts to promote Masi, adopting this innovation faced multiple obstacles, regardless of its performance. We explored the perceptions among healthcare personnel towards incorporating Masi to provide ventilatory support to COVID-19 patients during the second wave in Peru (January to June 2021).MethodsWe conducted twelve in-depth virtual interviews. Topics included experience when handling Masi, the impact of the training received, confidence in the device, barriers perceived, and enablers identified. All participants provided verbal informed consent.ResultsMost of the participants were male physicians. Participants belonged to seven hospitals that exhibited a wide range of healthcare capacities. Globally, the adoption of Masi MV was driven by the scarcity of ventilatory devices in the wards and reinforced by appropriate training and prompt technical support. Participants reported that Masi's structural and operational features played both advantages and disadvantages. Hospital infrastructure readiness, availability of commercial MVs, mistrust in its simple appearance, and resistance to change among healthcare personnel were perceived as barriers, while low-cost, prompt technical support and user-friendliness were valuable enablers. The first two enablers were observed in participants regardless of their attitude towards Masi. Despite the small number of participants for this qualitative study, it is important to note that the sample size was sufficient to reach saturation, as the topics discussed with participants became redundant and did not yield new information.ConclusionsThe perceptions among healthcare personnel to incorporate Masi as a mechanical ventilator for COVID-19 patients showed that communication, training and experience, and peer encouragement were essential to secure its use and sustainability of the technology. A priori judgments and perceptions unrelated to the performance of the novel device were observed, and its proper management may define its further implementation. Altogether our study suggests that along with strengthening local technological development, strategies to improve their adoption process must be considered as early as possible in medical innovations.
| S-EPMC10558817 | biostudies-literature
Project description: Not available
| S-BSST1055 | biostudies-other
Project description:IntroductionThe COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator.MethodsUsing previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic.ResultsDuring the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator.ConclusionsThe ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations.
| S-EPMC9212985 | biostudies-literature
Project description:Background: The urgent need for mechanical ventilators to support respiratory insufficiency due to SARS-CoV-2 led to a worldwide effort to develop low-cost, easily assembled, and locally manufactured ventilators. The ATENA ventilator project was developed in a community-based approach targeting the development, prototyping, testing, and decentralized manufacturing of a new mechanical ventilator. Objective: This article aims to demonstrate ATENA's adequate performance and safety for clinical use. Material: ATENA is a low-cost ventilator that can be rapidly manufactured, easily assembled, and locally produced anywhere in the world. It was developed following the guidelines and requirements provided by European and International Regulatory Authorities (MHRA, ISO 86201) and National Authorities (INFARMED). The device was thoroughly tested using laboratory lung simulators and animal models. Results: The device meets all the regulatory requirements for pandemic ventilators. Additionally, the pre-clinical experiences demonstrated security and adequate ventilation and oxygenation, in vivo. Conclusion: The ATENA ventilator had a good performance in required tests in laboratory scenarios and pre-clinical studies. In a pandemic context, ATENA is perfectly suited for safely treating patients in need of mechanical ventilation.
| S-EPMC8418230 | biostudies-literature
Project description: Not available
| S-EPMC7605199 | biostudies-literature
Project description: Not available
| S-EPMC7427377 | biostudies-literature
Project description:To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.
| 2346925 | ecrin-mdr-crc
Project description:BackgroundMechanical ventilation (MV) via tracheostomy is performed commonly for patients who are in long-term acute care hospitals (LTACHs) after respiratory failure. However, the outcome of MV in COVID-19-associated respiratory failure in LTACHs is not known.Research questionWhat is the ventilator liberation rate of patients who have received tracheostomy with COVID-19-associated respiratory failure compared with those with respiratory failure unrelated to COVID-19 in LTACHs?Study design and methodsIn this retrospective cohort study, we examined mechanically ventilated patients discharged between June 2020 and March 2021. Of 242 discharges, 165 patients who had undergone tracheostomy arrived and were considered for ventilator liberation. One hundred twenty-eight patients did not have COVID-19 and 37 patients were admitted for COVID-19.ResultsThe primary outcome of the study was ventilator liberation; secondary outcomes were functional recovery, length of stay (LOS) at the LTACH, and discharge disposition. After controlling for demographics, the number of comorbidities, hemodialysis, vasopressor need, thrombocytopenia, and the LOS at the short-term acute care hospital, our results indicated that patients with COVID-19 showed a higher adjusted ventilator liberation rate of 91.4% vs 56.0% in those without COVID-19. Functional ability was assessed with the change of Functional Status Score for the Intensive Care Unit (FSS-ICU) between admission and discharge. The adjusted mean change in FSS-ICU was significantly higher in the COVID-19 group than in the non-COVID-19 group: 9.49 (95% CI, 7.38-11.6) vs 2.08 (95% CI, 1.05-3.11), respectively (P < .001). Patients with COVID-19 experienced a shorter adjusted LOS at the LTACH with an adjusted hazard ratio of 1.57 (95% CI, 1.0-2.46; P = .05) compared with patients without COVID-19. We did not observe significant differences between the two groups regarding discharge location, but a trend toward need for lower level of care was found in patients with COVID-19.InterpretationOur study suggests that patients with COVID-19 requiring MV and tracheostomy have a higher chance for recovery than those without COVID-19.
| S-EPMC8875856 | biostudies-literature
Project description:Primary outcome(s): The incidence of obstructive colorectal cancer
| 2656898 | ecrin-mdr-crc