Aerosol delivery to young children by pMDI‐spacer: Is facemask design important?

Abstract

This study aimed at identifying in a daily-life setting the influence of facemask design on drug delivery via a spacer to young children. In a 4-week randomized crossover study, 24 children (7-23-months old) with recurrent wheeze tested the AstraZeneca, Galemed, and Hans Rudolph facemask combined with the NebuChamber at home. Each mask was tested twice daily for seven consecutive days. Filters positioned between the NebuChamber and facemask trapped the budesonide aerosol (200 microg, Pulmicort). Parents were asked to score the child's degree of cooperation during administration on diary cards. The administration procedure was evaluated through video recordings. Mean filter dose (standard deviation (s.d.)), expressed as % of nominal dose, was 39% (14), 47% (12), and 42% (11) for the AstraZeneca, the Galemed and the Hans Rudolph mask, respectively. Irrespective of the degree of cooperation, the Galemed mask gave significantly higher mean filter doses than the other masks (level of significance) (p < 0.045). Median (range) within-subject dose variability, expressed, as coefficient of variation (CV), was 37% (19-255), 32% (9-114), and 30% (9-115) for the AstraZeneca mask, the Galemed mask and the Hans Rudolph mask, respectively, not significant. Dose variability increased with decreasing cooperation for all three masks (p = 0.007). Drug delivery to young children with recurrent wheeze by means of the NebuChamber can be enhanced using the Galemed facemask. Dose variability seems to be independent of facemask design but mainly depends on cooperation.

Effect of nebulizer type, delivery interface, and flow rate on aerosol drug delivery to spontaneously breathing pediatric and infant lung models

“…Because small children cannot use a MP effectively, a FM is commonly utilized as a patient interface during aerosol therapy. Previous studies have noted the importance of the FM seal for efficient drug delivery to children . However, when the FM is used to deliver aerosolized medications, clinicians may fail to achieve a good FM seal.…”

“…Previous studies have noted the importance of the FM seal for efficient drug delivery to children. [12][13][14][15][16] However, when the FM is used to deliver aerosolized medications, clinicians may fail to achieve a good FM seal. Further, when clinicians attempt to have a tight seal between the face and the mask, young children may fuss and cry during therapy.…”

Performance Comparisons of Jet and Mesh Nebulizers Using Different Interfaces in Simulated Spontaneously Breathing Adults and Children

“…Previous studies emphasized the importance of a good face mask seal and reported that the face mask was not tolerated by children during aerosol therapy. (12)(13)(14)(15)(16)(17)(18)(19)(20) Also, the practice of blow-by, directing the stream of aerosol to the face of a child has been associated with reduced delivery compared to a tightly fitting mask, with variable deposition associated with nebulizer type. (21) Although nebulizers are well-established devices in aerosol medicine, there are different types of nebulizers and interfaces used for aerosol therapy that raise some practical questions among clinicians in the treatment of adults and pediatrics with pulmonary diseases.…”

Effect of Facial Material Softness and Applied Force on Face Mask Dead Volume, Face Mask Seal, and Inhaled Corticosteroid Delivery Through an Idealized Infant Replica

“…Unfortunately, a lack of cooperation from the infant can prevent an adequate FMS. (6)(7)(8)(9) This lack of cooperation, often in the form of crying or screaming, may result in increased extrathoracic deposition due to higher peak inspiratory flow rates. (6) Using toys, videos, or making a game of the aerosol administration process, (1,10) as well as using a pacifier in the face mask, (11,12) have been suggested to increase patient adherence to this form of therapy.…”