Objective The paucity of mechanical ventilators necessitates development of innovative respiratory support devices.
Methods We developed the Artificial Breathing Capability Device (ABCD) to automate compression of self-inflating bags (SIB), while controlling peak inspiratory pressure (PIP), ventilation rate (VR) and inspiration to expiration time (I:E) ratio (as in a conventional ventilator). ABCD has additional smart features including self-regulatory checks, auto cut-off during cough, endotracheal tube disconnection and blockage alarms, and SIB disconnection alarm. ABCD was tested non-stop for 60 days with 396 user combinations, using adult-size and paediatric-size SIB. The device was evaluated for robustness, reliability and precision.
Results ABCD did not have mechanical, electrical or electronic failures during continuous testing under various ambient conditions, confirming robustness. Reliability and precision evaluated by the proportion of user combinations showing <10% deviation from the set parameters showed: PIP 100%, VR 100% and I:E 84.3% with an adult SIB. The corresponding proportions with a paediatric-size SIB were 85.4%, 100% and 95.5%. With both SIB, the only combinations showing >10% deviation were outside the physiologic range.
Conclusion ABCD is a safe, efficacious and cost-effective option, which could be considered for adults and children in the context of ventilator shortages especially during the COVID-19 pandemic.
- respiratory tract diseases
- critical care
- pulmonary medicine
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Contributors JLM conceptualised the device and its clinical specifications, observed manual ventilation for several weeks to identify the user needs, secured funding, supervised the development and clinical testing of the device, drafted and finalised the manuscript. MS, AG, NK and AC assisted with design and development of the device, under the overall supervision of JLM and MS. MS was incharge of the mechanical aspects of the device and S was incharge of the electronics components. AG performed the testing under the supervision of JLM and MS. PJM contributed critical inputs during the design, development, testing phase and manuscript preparation. All authors approved the final manuscript.
Funding Partial funding support was received from the Department of Science and Technology, New Delhi, Government of India for the development and testing phase of ABCD, as well as salary of research staff. Partial funding support was received from Esteem Industries Baddi, Solan, Himachal Pradesh, India for procurement of consumables, stipends to interns, and manufacturing the cabinet for ABCD. The lead author (JLM) contributed funds from personal resources during the early design and development phase.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This research was initiated with approval of the Institutional Ethics Committee of the Postgraduate Institute of Medical Education and Research, Chandigarh, India vide letter no. PGI/IEC/2016/3573 dated 5 November 2016.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as online supplemental information.