scholarly journals In Vitro Performance of an Investigational Vibrating-Membrane Nebulizer with Surfactant under Simulated, Non-Invasive Neonatal Ventilation Conditions: Influence of Continuous Positive Airway Pressure Interface and Nebulizer Positioning on the Lung Dose

Pharmaceutics ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 257 ◽  
Author(s):  
Federico Bianco ◽  
Elena Pasini ◽  
Marcello Nutini ◽  
Xabier Murgia ◽  
Carolin Stoeckl ◽  
...  

Non-invasive delivery of nebulized surfactant has been a long-pursued goal in neonatology. Our aim was to evaluate the performance of an investigational vibrating-membrane nebulizer in a realistic non-invasive neonatal ventilation circuit with different configurations. Surfactant (aerosols were generated with a nebulizer in a set-up composed of a continuous positive airway pressure (CPAP) generator with a humidifier, a cast of the upper airway of a preterm infant (PrINT), and a breath simulator with a neonatal breathing pattern. The lung dose (LD), defined as the amount of surfactant collected in a filter placed at the distal end of the PrINT cast, was determined after placing the nebulizer at different locations of the circuit and using either infant nasal mask or nasal prongs as CPAP interfaces. The LD after delivering a range of nominal surfactant doses (100–600 mg/kg) was also investigated. Surfactant aerosol particle size distribution was determined by laser diffraction. Irrespective of the CPAP interface used, about 14% of the nominal dose (200 mg/kg) reached the LD filter. However, placing the nebulizer between the Y-piece and the CPAP interface significantly increased the LD compared with placing it 7 cm before the Y-piece, in the inspiratory limb. (14% ± 2.8 vs. 2.3% ± 0.8, nominal dose of 200 mg/kg). The customized eFlow Neos showed a constant aerosol generation rate and a mass median diameter of 2.7 μm after delivering high surfactant doses (600 mg/kg). The customized eFlow Neos nebulizer showed a constant performance even after nebulizing high doses of undiluted surfactant. Placing the nebulizer between the Y-piece and the CPAP interface achieves the highest LD under non-invasive ventilation conditions.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Arash Malakian ◽  
Mohammad Reza Aramesh ◽  
Mina Agahin ◽  
Masoud Dehdashtian

Abstract Background The most common cause of respiratory failure in premature infants is respiratory distress syndrome. Historically, respiratory distress syndrome has been treated by intratracheal surfactant injection followed by mechanical ventilation. In view of the risk of pulmonary injury associated with mechanical ventilation and subsequent chronic pulmonary lung disease, less invasive treatment modalities have been suggested to reduce pulmonary complications. Methods 148 neonates (with gestational age of 28 to 34 weeks) with respiratory distress syndrome admitted to Imam Khomeini Hospital in Ahwaz in 2018 were enrolled in this clinical trial study. 74 neonates were assigned to duo positive airway pressure (NDUOPAP) group and 74 neonates to nasal continuous positive airway pressure (NCPAP) group. The primary outcome in this study was failure of N-DUOPAP and NCPAP treatments within the first 72 h after birth and secondary outcomes included treatment complications. Results there was not significant difference between DUOPAP (4.1 %) and NCPAP (8.1 %) in treatment failure at the first 72 h of birth (p = 0.494), but non-invasive ventilation time was less in the DUOPAP group (p = 0.004). There were not significant differences in the frequency of patent ductus arteriosus (PDA), pneumothorax, intraventricular hemorrhage (IVH) and bronchopulmonary dysplasia (BPD), apnea and mortality between the two groups. Need for repeated doses of surfactant (p = 0.042) in the NDUOPAP group was significantly lower than that of the NCPAP group. The duration of oxygen therapy in the NDUOPAP group was significantly lower than that of the NCPAP group (p = 0.034). Also, the duration of hospitalization in the NDUOPAP group was shorter than that of the NCPAP group (p = 0.002). Conclusions In the present study, DUOPAP compared to NCPAP did not reduce the need for mechanical ventilation during the first 72 h of birth, but the duration of non-invasive ventilation and oxygen demand, the need for multiple doses of surfactant and length of stay in the DUOPAP group were less than those in the CPAP group. Trial registration IRCT20180821040847N1, Approved on 2018-09-10.


Pneumologie ◽  
2021 ◽  
Author(s):  
Wolfram Windisch ◽  
Bernd Schönhofer ◽  
Daniel Sebastian Majorski ◽  
Maximilian Wollsching-Strobel ◽  
Carl-Peter Criée ◽  
...  

ZusammenfassungIn der Corona-Pandemie werden zunehmend nicht-invasive Verfahren zur Behandlung des akuten hypoxämischen Versagens bei COVID-19 eingesetzt. Hier stehen mit der HFOT (high-flow oxygen therapy), CPAP (continuous positive airway pressure) und der NIV (non-invasive ventilation) unterschiedliche Verfahren zur Verfügung, die das Ziel einer Intubationsvermeidung verfolgen. Der aktuelle Übersichtsartikel fasst die heterogene Studienlage zusammen. Wesentlich ist die Erkenntnis, dass diese nicht-invasiven Verfahren durchaus auch bei einem schweren, akuten hypoxämischen Versagen erfolgreich sein können und damit die Intubation wie auch Tubus-assoziierte Komplikationen vermeiden können. Demgegenüber bleibt aber ebenso zu betonen, dass die prolongierte unterstützte Spontanatmung ebenfalls zu Komplikationen führt und dass demzufolge insbesondere ein spätes NIV-Versagen mit erheblich verschlechterter Prognose einhergeht, was vor dem Hintergrund weiterhin hoher NIV-Versagensraten in Deutschland bedeutsam ist. Der aktuelle Artikel verweist schließlich auch auf einen Parallelartikel in dieser Ausgabe, der die medial in der Öffentlichkeit in Deutschland geführte Debatte zu diesem Thema aufgreift und deren inhaltliche Fragwürdigkeit, aber auch die negativen Auswirkungen auf die Gesellschaft und die Fachwelt adressiert. Gleichzeitig wird die Bedeutung von regelmäßig zu überarbeitenden Leitlinien untermauert.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038002 ◽  
Author(s):  
Alvin Richards-Belle ◽  
Peter Davis ◽  
Laura Drikite ◽  
Richard Feltbower ◽  
Richard Grieve ◽  
...  

IntroductionEven though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.Methods and analysisWe will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one sided) to exclude the prespecified non-inferiority margin of HR of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations.Ethics and disseminationThis master protocol received favourable ethical opinion from National Health Service East of England—Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.Trial registration numberISRCTN60048867


Author(s):  
Josep Masip ◽  
Kenneth Planas ◽  
Arantxa Mas

During the last 25 years, the use of non-invasive ventilation has grown substantially. Non-invasive ventilation refers to the delivery of positive pressure to the lungs without endotracheal intubation and plays a significant role in the treatment of patients with acute respiratory failure and in the domiciliary management of some chronic respiratory and sleep disorders. In the intensive and acute care setting, the primary aim of non-invasive ventilation is to avoid intubation, and it is mainly used in patients with chronic obstructive pulmonary disease exacerbations, acute cardiogenic pulmonary oedema, or in the context of weaning, situations in which a reduction in mortality has been demonstrated. The principal techniques are continuous positive airway pressure and bilevel pressure support ventilation. Whereas non-invasive pressure support ventilation requires a ventilator, continuous positive airway pressure is a simpler technique that can be easily used in non-equipped areas such as the pre-hospital setting. The success of non-invasive ventilation is related to the adequate timing and selection of patients, as well as the appropriate use of interfaces, the synchrony of patient-ventilator, and the fine-tuning of the ventilator.


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