Randomised study of a new inline respiratory function monitor (Juno) to improve mask seal and delivered ventilation with neonatal manikins

Background Respiratory function monitors (RFM) have been used extensively in manikin and infant studies yet have not become the standard of training. We report the outcomes of a new portable, lightweight resuscitation monitor (Juno) designed to show mask leak and deflation tidal volume to assist in positive pressure ventilation (PPV) competency training using manikins. Methods Two leak-free manikins (Preterm and Term) were used. Participants provided positive pressure ventilation to manikins using two randomized devices self-inflating bag (SIB) and T-piece resuscitator (TPR) with Juno display initially blinded then unblinded in four 90-second paired sequences, aiming for adequate chest wall rise and target minimal mask leak with appropriate target delivered volume when using the monitor. Results 49 experienced neonatal staff delivered 15,569 inflations to the term manikin and 14,580 inflations to the preterm. Comparing blinded to unblinded RFM display there were significant reductions in all groups in the number of inflations out of target range volumes (Preterm: SIB 22.6% to 6.6%, TPR: 7.1% to 4.2% and Term: SIB 54.8% to 37.8%, TPR 67.2 to 63.8%). The percentage of mask leak inflations >60% was reduced in Preterm: SIB 20.7% to 7.2%, TPR 23.4% to 7.4% and in Term: SIB 8.7% to 3.6%, TPR 23.5% to 6.2%). Conclusions Using the Juno monitor during simulated resuscitation significantly improved mask leak and delivered ventilation amongst otherwise experienced staff, using both preterm and term manikins. The Juno is a novel RFM that may assist in teaching and self-assessment of resuscitation technique. What is already known on this topic What this study adds How this study might affect research, practice or policy ### Competing Interest Statement The ResusRight is a startup company founded by Mark Tracy, Murray Hinder, Matthew Crott and Matthew Boustred to commercialise the prototype Juno monitor studied. Mark Tracy is an unpaid medical consultant for the ResusRight and a minor share holder. Murray Hinder is an unpaid engineering consultant for the ResusRight and a minor share holder. Matthew Crott is a Director and Chief Technical Officer for Resusright and is a shareholder. Matthew Boustred is a Director and Chief Executive Officer for ResusRight and is a shareholder. ### Funding Statement Juno monitor was developed via public funded grant Cerebral Palsy Alliance (research grant #PG14118) and Matthew Crott and Matthew Boustred PhD candidates, University of Sydney conducting prototype development ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approval was obtained from Sydney Childrens Hospital Network ethics committee NSW Australia 2019 ETH13537 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors