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Endotracheal Tube, Cuffed

Breathing bag

Breathing bag

Description
  • Breathing bag
Ref. No.: Type: Descriptions:
NMR103414 Wye Connector A 22M / 15F, 15M
NMR103405 Wye Connector B 22M / 15F, 22M
NMR103406 Wye Connector C With sample port, 22M / 15F, 22M
NMR103407 Corner Connector 22M / 15F, 15M
NMR103403 Disposable Water Trap /
NMR103409 Connector jiont 22M / 22F
NMR103410 Breathing Bag Latex-free, 0.5L, green
NMR103411 Breathing Bag Latex-free, , green
NMR103412 Breathing Bag Latex-free, , green
NMR103413 Breathing Bag Latex-free, , green
NMR103417 Breathing Bag Latex, 0.5L, blue
NMR103418 Breathing Bag Latex, 1L, blue
NMR103419 Breathing Bag Latex, 2L, blue
NNMR103420 Breathing Bag Latex, 3L, blue
Breathing Bag, The COVID-19 pandemic has caused a global mechanical ventilator shortage for treatment of severe acute respiratory failure. The development of novel breathing devices has been proposed as a low-cost, rapid solution when full-featured ventilators are unavailable. Here we report the design, bench testing, and preclinical results for an 'Automated Bag Breathing Unit' (ABBU). Output parameters were validated with mechanical test lungs followed by animal model testing.

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Breathing bag

Results

The ABBU design uses a programmable motor-driven wheel assembled for adult resuscitation bag-valve compression. ABBU can control tidal volume (200–800 ml), respiratory rate (10–40 bpm), inspiratory time (0.5–1.5 s), assist pressure sensing (− 1 to − 20 cm H2O), manual PEEP valve (0–20 cm H2O). All set values are displayed on an LCD screen. Bench testing with lung simulators (Michigan 1600, Breathing bag SmartLung 2000) yielded consistent tidal volume delivery at compliances of 20, 40, and 70 (mL/cm H2O). The delivered fraction of inspired oxygen (FiO2) decreased with increasing minute ventilation (VE), from 98 to 47% when VE was increased from 4 to 16 L/min using a fixed oxygen flow source of 5 L/min. ABBU was tested in Berkshire pigs (n = 6, weight of 50.8 ± 2.6 kg) utilizing a normal lung model and saline lavage-induced lung injury. Arterial blood gases were measured following changes in tidal volume (200–800 ml), respiratory rate (10–40 bpm), and PEEP (5–20 cm H2O) at baseline and after lung lavage. Physiological levels of PaCO2 (≤ 40 mm Hg [5.3 kPa]) were achieved in all animals at baseline and following lavage injury. PaO2 increased in lavage injured lungs in response to incremental PEEP (5–20 cm H2O) (p < 0.01). At fixed low oxygen flow rates (5 L/min), delivered FiO2 decreased with increased VE.

Conclusions

ABBU provides oxygenation and ventilation across a range of parameter settings that may potentially provide a low-cost solution to ventilator shortages. A clinical trial is necessary to establish safety and efficacy in adult patients with diverse etiologies of respiratory failure.

Background

On January 31, 2020, the US Department of Health & Human Services announced a public health emergency related to a novel coronavirus, SARS-CoV-2, and the disease it causes, COVID-19. The early rapid spread of the COVID-19 pandemic resulted in a shortage of mechanical ventilators and accessory components (e.g., humidifiers, circuits, etc.) in many regions throughout the world. In response to these shortages, a global surge in development and production occurred, including repurposing non-medical device assembly lines to manufacture quickly designed ventilators (e.g., FORD, GM, Virgin, etc.) As of March 2021, over 150 million COVID-19 cases have been identified leading to over 3.0 million deaths worldwide. Among hospitalized patients, 30% require care at intensive care unit (ICU) and 29% or more of those require mechanical ventilation In response to the shortage of mechanical ventilators to treat COVID-19 patients, resuscitation bag-valve breathing devices were conceived as a potential solution for short-term emergency use. The FDA has classified these devices as "emergency resuscitators" to distinguish them from mechanical ventilators. Our design uses a self-inflating resuscitation bag-valve, an automobile windshield motor, and lever arm to mimic manual hand bag-valve ventilation—along with essential operator controllable parameters: tidal volume (VT), respiratory rate (RR), inspiratory time (TI), positive end-expiratory pressure (PEEP) and patient-initiated breath pressure sensing. ABBU uses readily available components, low flow O2 sources, standard electrical power, and can be rapidly mass-produced at lower cost ($2,000 estimated at 2021, ~ 5 h per unit production) compare to the full-featured ICU ventilator ($25,000–$50,000). The purpose of this study was to determine if ABBU can provide oxygenation and ventilation in a mechanical test lung and preclinical porcine model across a range of clinically relevant parameter settings.