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. 2024 May 2;19(5):e0300241.
doi: 10.1371/journal.pone.0300241. eCollection 2024.

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Daniel Göhler  1   2 , Kathrin Oelschlägel  1 , Mehdi Ouaissi  3   4 , Urs Giger-Pabst  3   5
Affiliations

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Daniel Göhler et al. PLoS One. .

Abstract

Objective: Technical ex-vivo comparison of commercial nebulizer nozzles used for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC).

Methods: The performance of four different commercial nebulizer nozzles (Nebulizer; HurriChemTM; MCR-4 TOPOL®; QuattroJet) was analysed concerning: i) technical design and principle of operation, ii) operational pressure as function of the liquid flow rate, iii) droplet size distribution via laser diffraction spectrometry, iv) spray cone angle, spray cone form as well as horizontal drug deposition by image-metric analyses and v) chemical resistance via exposing to a cytostatic solution and chemical composition by means of spark optical emission spectral analysis.

Results: The Nebulizer shows quasi an identical technical design and thus also a similar performance (e.g., mass median droplet size of 29 μm) as the original PIPAC nozzles (MIP/ CapnoPen). All other nozzles show more or less a performance deviation to the original PIPAC nozzles. The HurriChemTM has a similar design and principle of operation as the Nebulizer, but provides a finer aerosol (22 μm). The principle of operation of MCR-4 TOPOL® and QuattroJet differ significantly from that of the original PIPAC nozzle technology. The MCR-4 TOPOL® offers a hollow spray cone with significantly larger droplets (50 μm) than the original PIPAC nozzles. The QuattroJet generates an aerosol (22 μm) similar to that of the HurriChemTM but with improved spatial drug distribution.

Conclusion: The availability of new PIPAC nozzles is encouraging but can also have a negative impact if their performance and efficacy is unknown. It is recommended that PIPAC nozzles that deviate from the current standard should be subject to bioequivalence testing and implementation in accordance with the IDEAL-D framework prior to routine clinical use.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. 90° sectional views of the head regions of the nozzles.
O = outlet orifice; H = nozzle head; I = bar inlay with distal transverse borehole; M = double metal grid; N = fixed needle; S = shaft; T = twist body.
Fig 2
Fig 2. Light microscopic images of the outlet orifices with determined orifice diameters of the examined nozzles; scaling in mm.
Fig 3
Fig 3. Operational pressure as function of the liquid flow rate from barometric analyses (a), mass median diameter as function of the operational pressure from granulometric analyses (b) and volume-weighted distributions density (c) and cumulative distribution (d) of droplets at certain manufacturer-recommended operational condition; black cycles/ellipses indicate manufacturer-recommended operation condition.
Fig 4
Fig 4. Photographic images of spray cone angle (upper panel), of spray cone form (middle panel) and horizontal drug deposition area (lower panel, scale in cm).
Fig 5
Fig 5. Photographic images of the nozzle parts after exposure to the cytostatic solution.
See this image and copyright information in PMC

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