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.
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