Objective To assess leakage caused by the Pedi-Cap.
Methods Bench test I: Pedi-Caps were connected between the Neopuff and a test lung and placed underwater to detect the leak. Bench test II: the disposable Avea VarFlex Flow Transducer measured the leak. Retrospective analysis: recordings of intubations in the delivery room were analysed.
Results The (rippled) male end of the Pedi-Cap is the origin of the leak. In bench test I, 32% of the Pedi-Caps caused inevitable extensive leaks and 34% caused leaks that diminished after sealing the end. In bench test II (n=44) and the retrospective analysis (n=17), the flow transducer measured 22% (18–60) and 39% (8–82) leakage, respectively. Leakage decreased after removal of the Pedi-Cap (before vs after; 17% (7–75) vs 4% (2–10), p=0.004).
Conclusion The Pedi-Cap causes the leak which can compromise respiratory support. We recommend to remove the Pedi-Cap directly after change of colour and to be cautious when using the device as evaluation tool.
- endotracheal intubation
- respiratory support
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Contributors ABP conceptualised and designed the study, was involved in data analysis and interpretation, and reviewed and revised the manuscript. AH and TM contributed to the literature search, data acquisition, analysis and interpretation. TM drafted the manuscript. SJEC, RNGBT and SBH were involved in data interpretation.
Funding ABP is a recipient of an NWO innovational research incentives scheme (VIDI 91716428).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval In compliance with the Dutch law on Medical Research in Humans, this study did not require consent from an ethics committee. The local institution Research Ethics Committee of the LUMC issued a statement of no objection.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.