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Ideation and assessment of a nitric oxide delivery system for spontaneously breathing subjects.

ABSTRACT: BACKGROUND:There is an increasing interest in safely delivering high dose of inhaled nitric oxide (NO) as an antimicrobial and antiviral therapeutics for spontaneously breathing patients. A novel NO delivery system is described. METHODS:We developed a gas delivery system that utilizes standard respiratory circuit connectors, a reservoir bag, and a scavenging chamber containing calcium hydroxide. The performance of the system was tested using a mechanical lung, assessing the NO concentration delivered at varying inspiratory flows. Safety was assessed in vitro and in vivo by measuring nitrogen dioxide (NO2) levels in the delivered NO gas. Lastly, we measured the inspired and expired NO and NO2 of this system in 5 healthy subjects during a 15-min administration of high dose NO (160 parts-per-million, ppm) using our delivery system. RESULTS:The system demonstrated stable delivery of prescribed NO levels at various inspiratory flow rates (0-50 L/min). The reservoir bag and a high flow of entering air minimized the oscillation of NO concentrations during inspiration on average 4.6 ppm for each 10 L/min increment in lung inspiratory flow. The calcium hydroxide scavenger reduced the inhaled NO2 concentration on average 0.9 ppm (95% CI -1.58, -0.22; p = .01). We performed 49 NO administrations of 160 ppm in 5 subjects. The average concentration of inspired NO was 164.8±10.74 ppm, with inspired NO2 levels of 0.7±0.13 ppm. The subjects did not experience any adverse events; transcutaneous methemoglobin concentrations increased from 1.05±0.58 to 2.26±0.47%. CONCLUSIONS:The system we developed to administer high-dose NO for inhalation is easy to build, reliable, was well tolerated in healthy subjects.

SUBMITTER: Gianni S

PROVIDER: S-EPMC7441999 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Ideation and assessment of a nitric oxide delivery system for spontaneously breathing subjects.

Gianni Stefano S Morais Caio C A CCA Larson Grant G Pinciroli Riccardo R Carroll Ryan R Yu Binglan B Zapol Warren M WM Berra Lorenzo L

Nitric oxide : biology and chemistry 20200821

<h4>Background</h4>There is an increasing interest in safely delivering high dose of inhaled nitric oxide (NO) as an antimicrobial and antiviral therapeutics for spontaneously breathing patients. A novel NO delivery system is described.<h4>Methods</h4>We developed a gas delivery system that utilizes standard respiratory circuit connectors, a reservoir bag, and a scavenging chamber containing calcium hydroxide. The performance of the system was tested using a mechanical lung, assessing the NO con ...[more]

PMID: 32835810

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Project description:the current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health. The number of infected patients is continuously increasing and the need for Intensive Care Unit admission ranges from 5 to 26%. The mortality is reported to be around 3.4% with higher values for the elderly and in patients with comorbidities. Moreover, this condition is challenging the healthcare system where the outbreak reached its highest value. To date there is still no available treatment for SARS-CoV-2. Clinical and preclinical evidence suggests that nitric oxide (NO) has a beneficial effect on the coronavirus-mediated acute respiratory syndrome, and this can be related to its viricidal effect. The time from the symptoms' onset to the development of severe respiratory distress is relatively long. We hypothesize that high concentrations of inhaled NO administered during early phases of COVID-19 infection can prevent the progression of the disease. This is a multicenter randomized controlled trial. Spontaneous breathing patients admitted to the hospital for symptomatic COVID-19 infection will be eligible to enter the study. Patients in the treatment group will receive inhaled NO at high doses (140-180 parts per million) for 30 minutes, 2 sessions every day for 14 days in addition to the hospital care. Patient in the control group will receive only hospital care. The primary outcome is the percentage of patients requiring endotracheal intubation due to the progression of the disease in the first 28 days from enrollment in the study. Secondary outcomes include mortality at 28 days, proportion of negative test for SARS-CoV-2 at 7 days and time to clinical recovery. The trial protocol has been approved at the Investigation Review Boards of Xijing Hospital (Xi'an, China) and The Partners Human Research Committee of Massachusetts General Hospital (Boston, USA) is pending. Recruitment is expected to start in March 2020. Results of this study will be published in scientific journals, presented at scientific meetings, and on related website or media in fighting this widespread contagious disease.

Project description:Patients who increase stoke volume or cardiac index more than 10 or 15% after a fluid challenge are usually considered fluid responders. Assessment of fluid responsiveness prior to volume expansion is critical to avoid fluid overload, which has been associated with poor outcomes. Maneuvers to assess fluid responsiveness are well established in mechanically ventilated patients; however, few studies evaluated maneuvers to predict fluid responsiveness in spontaneously breathing patients. Our objective was to perform a systematic review of literature addressing the available methods to assess fluid responsiveness in spontaneously breathing patients. Studies were identified through electronic literature search of PubMed from 01/08/2009 to 01/08/2016 by two independent authors. No restrictions on language were adopted. Quality of included studies was evaluated with Quality Assessment of Diagnostic Accuracy Studies tool. Our search strategy identified 537 studies, and 9 studies were added through manual search. Of those, 15 studies (12 intensive care unit patients; 1 emergency department patients; 1 intensive care unit and emergency department patients; 1 operating room) were included in this analysis. In total, 649 spontaneously breathing patients were assessed for fluid responsiveness. Of those, 340 (52%) were deemed fluid responsive. Pulse pressure variation during the Valsalva maneuver (?PPV) of 52% (AUC ± SD: 0.98 ± 0.03) and passive leg raising-induced change in stroke volume (?SV-PLR) > 13% (AUC ± SD: 0.96 ± 0.03) showed the highest accuracy to predict fluid responsiveness in spontaneously breathing patients. Our systematic review indicates that regardless of the limitations of each maneuver, fluid responsiveness can be assessed in spontaneously breathing patients. Further well-designed studies, with adequate simple size and power, are necessary to confirm the real accuracy of the different methods used to assess fluid responsiveness in this population of patients.

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Ideation and assessment of a nitric oxide delivery system for spontaneously breathing subjects.

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Ideation and assessment of a nitric oxide delivery system for spontaneously breathing subjects.

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