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. 2024 Oct;38(5):1155-1162.
doi: 10.1007/s10877-024-01143-4. Epub 2024 Jun 1.

A novel, cassette-based nitric oxide delivery system with an advanced feedback control algorithm accurately delivers nitric oxide via the anesthesia machine independent of fresh gas flow rate and volatile anesthetic agent

Mark D Twite  1 , Aaron W Roebuck  2 , Stephanie R Anderson  3
Affiliations

A novel, cassette-based nitric oxide delivery system with an advanced feedback control algorithm accurately delivers nitric oxide via the anesthesia machine independent of fresh gas flow rate and volatile anesthetic agent

Mark D Twite et al. J Clin Monit Comput. 2024 Oct.

Abstract

Nitric oxide (NO), a selective pulmonary vasodilator, can be delivered via conventional ICU and anesthesia machine ventilators. Anesthesia machines are designed for rebreathing of circulating gases, reducing volatile anesthetic agent quantity used. Current cylinder- and ionizing-based NO delivery technologies use breathing circuit flow to determine NO delivery and do not account for recirculated gases; therefore, they cannot accurately dose NO at FGF below patient minute ventilation (MV). A novel, cassette-based NO delivery system (GENOSYL® DS, Vero Biotech Inc.) uses measured NO concentration in the breathing circuit as an input to an advanced feedback control algorithm, providing accurate NO delivery regardless of FGF and recirculation of gases. This study evaluated GENOSYL® DS accuracy with different anesthesia machines, ventilation parameters, FGFs, and volatile anesthetics. GENOSYL® DS was tested with GE Aisys and Dräger Fabius anesthesia machines to determine NO dose accuracy with FGF < patient MV, and with a Getinge Flow-i anesthesia machine to determine NO dose accuracy when delivering various volatile anesthetic agents. Neonatal and adult mechanical ventilation parameters and circuits were used. GENOSYL® DS maintained accurate NO delivery with all three anesthesia machines, at low FGF with recirculation of gases, and with all volatile anesthetic agents at different concentrations. Measured NO2 levels remained acceptable at ≤ 1 ppm with set NO dose ≤ 40 ppm. GENOSYL® DS, with its advanced feedback control algorithm, is the only NO delivery system capable of accurately dosing NO with anesthesia machines with rebreathing ventilation parameters (FGF < MV) regardless of anesthetic agent.

Keywords: Anesthesia machine; Low-flow anesthesia; Nitric oxide.

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Conflict of interest statement

Mark D. Twite reports consulting fees from Vero Biotech Inc. Aaron W. Roebuck reports employment with and stock options in Vero Biotech Inc. Stephanie R. Anderson reports previous employment with Vero Biotech Inc. Patents are planned for the GENOSYL® Delivery System by Vero Biotech Inc. A Dräger Fabius GS Premium anesthesia machine was also provided by Dräger. The authors declare that the work described is original research that has not been published previously. All authors have approved the manuscript.

Figures

Fig. 1
Fig. 1
NO generation pathway, the GENOSYL® DS, and experimental setup. a The N2O4 to NO chemical conversion. b GENOSYL® DS measures NO concentration in the breathing circuit and uses the measured value in an advanced feedback-control algorithm to accurately determine how much NO should be injected when rebreathing in semi-closed anesthesia circuits. c Anesthesia experimental setup used a dual-limb anesthesia circuit with injection port at the inspiratory output of the machine. The sampling port was 6 to 12 inches from the patient wye on the inspiratory limb of the breathing circuit. DS delivery system, N2O4 dinitrogen tetroxide, NO nitric oxide
Fig. 2
Fig. 2
Accuracy of NO delivery using GENOSYL® DS in conjunction with GE and Dräger anesthesia machines in mechanical and manual ventilation modes. *Acceptance criteria were based on guidance for industry [23]. DS delivery system, NO nitric oxide
Fig. 3
Fig. 3
Accuracy of measured NO in neonatal and adult circuits using a Flow-i anesthesia machine in the absence of anesthetic agents and with different anesthetic agents and concentrations. The NO measurement displayed on the Genosyl® DS was recorded 10 min after anesthetic concentration changes. AD adult, FGF fresh gas flow, iNO inhaled NO, MAC minimum alveolar concentration, NEO, neonatal, NO nitric oxide, N2O nitrous oxide
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