Translational design for limited resource settings as demonstrated by Vent-Lock, a 3D-printed ventilator multiplexer
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Abstract
Background
Mechanical ventilators are essential to patients who become critically ill with acute respiratory distress syndrome (ARDS), and shortages have been reported due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Methods
We utilized 3D printing (3DP) technology to rapidly prototype and test critical components for a novel ventilator multiplexer system, Vent-Lock, to split one ventilator or anesthesia gas machine between two patients. FloRest, a novel 3DP flow restrictor, provides clinicians control of tidal volumes and positive end expiratory pressure (PEEP), using the 3DP manometer adaptor to monitor pressures. We tested the ventilator splitter circuit in simulation centers between artificial lungs and used an anesthesia gas machine to successfully ventilate two swine.
Results
As one of the first studies to demonstrate splitting one anesthesia gas machine between two swine, we present proof-of-concept of a de novo, closed, multiplexing system, with flow restriction for potential individualized patient therapy.
Conclusions
While possible, due to the complexity, need for experienced operators, and associated risks, ventilator multiplexing should only be reserved for urgent situations with no other alternatives. Our report underscores the initial design and engineering considerations required for rapid medical device prototyping via 3D printing in limited resource environments, including considerations for design, material selection, production, and distribution. We note that optimization of engineering may minimize 3D printing production risks but may not address the inherent risks of the device or change its indications. Thus, our case report provides insights to inform future rapid prototyping of medical devices.
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SciScore for 10.1101/2020.09.16.20195230: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: In vivo swine studies: Experiments were performed in accordance with the Guide for the Care and Use of Laboratory Animals and were approved by the Institutional Animal Care and Use Committee of Washington University School of Medicine (St. Louis, MO). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The swine were females, 72 kg each, 5 months old, and were Landrace-cross swine. Table 2: Resources
Software and Algorithms Sentences Resources MATLAB code used to analyze swine data MATLABsuggested: (MATLAB, RRID:SCR_001622)Results from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: …SciScore for 10.1101/2020.09.16.20195230: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: In vivo swine studies: Experiments were performed in accordance with the Guide for the Care and Use of Laboratory Animals and were approved by the Institutional Animal Care and Use Committee of Washington University School of Medicine (St. Louis, MO). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The swine were females, 72 kg each, 5 months old, and were Landrace-cross swine. Table 2: Resources
Software and Algorithms Sentences Resources MATLAB code used to analyze swine data MATLABsuggested: (MATLAB, RRID:SCR_001622)Results from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Some limitations to our study include lack of human testing. While the swine in this study had similar lung compliances which allowed us to show that the device was able to restrict flow and that there is a finite tidal volume that is necessary and it is unknown how well this reflects human physiology. In addition to urgent need, challenges in continuous monitoring must be addressed prior to human studies. Future directions include developing a more rigorous continuous monitoring of flow rates and delivered tidal volumes to patients to facilitate adjustments of flow per FloRest. This is critical due to the dynamic lung physiologies of patients with ARDS and preventing barotrauma or under or over ventilation. Therefore, we recommend setting a target lung volume per patient, and monitoring via spirometry or airflow transducers, such as the ones used in our swine studies (SS11LB airflow transducer (Biopac; Goleta, CA)). Patient lung volumes and their oxygenation statuses should be spot checked with the spirometer or transducers and arterial blood gases. Lastly, we emphasize that ventilator multiplexing is only to be used in emergency situations after all alternatives have been exhausted. Despite our findings of improved ventilator multiplexing functions with Vent-Lock and Vent-Lock FloRest, additional studies are required to validate the safety and clinical considerations prior to translation to human subjects. However, as future pandemics and disasters may exhaust standard-of-c...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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