Objective The International Liaison Committee on Resuscitation has found that there is a need for high-quality randomised trials of training interventions that improve the effectiveness of resuscitation skills. The objective of this study was to determine whether using a respiratory function monitor (RFM) during mask ventilation training with a manikin reduces facemask leak.
Design Stratified, parallel-group, randomised controlled trial. Outcome assessors were blinded to group allocation.
Setting Thirteen hospitals in Australia, including non-tertiary sites.
Participants Consecutive sample of healthcare professionals attending a structured newborn resuscitation training course.
Interventions An RFM providing real-time, objective, leak, flow and volume information was attached to the facemask during 1.5 hours of newborn ventilation and simulation training using a manikin. Participants were randomised to have the RFM display visible (intervention) or masked (control), using a computer-generated randomisation sequence.
Main outcome measures The primary outcome was facemask leak measured after neonatal facemask ventilation training. Tidal volume was an important secondary outcome measure.
Results Participants were recruited from May 2016 to November 2017. Of 402 eligible participants, two refused consent. Four hundred were randomised, 200 to each group, of whom 194 in each group underwent analysis. The median (IQR) facemask leak was 23% (8%–41%) in the RFM visible group compared with 35% (14%–67%) in the masked group, p<0.0001, difference (95% CI) in medians 12 (4 to 22).
Conclusions The display of information from an RFM improved the effectiveness of newborn facemask ventilation training.
Trial registration number ACTRN12616000542493, pre-results.
- respiratory function monitor
- medical education
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Contributors EOC made significant contributions to the study design, wrote the first draft of the protocol, collected data, carried out the initial analysis and data interpretation, and wrote the first draft of the manuscript. JAD conceptualised and designed the study, collected data, and reviewed and revised the manuscript. SMD made significant contributions to the design of the study, statistical plan, data analysis and interpretation, and reviewed and revised the manuscript. MT and PGD conceptualised and designed the study, supervised the project and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding This study was supported by the Australian Government National Health and Medical Research Council (App ID 1059111 to PGD, App ID 1111134 to MT, App ID 1113902 to PGD, JAD and MT, App ID 1060733 to EOC via a PhD scholarship and project grant from the Centre of Research Excellence in Newborn Medicine, Murdoch Children’s Research Institute).
Competing interests None declared.
Patient consent Not required.
Ethics approval The study was approved by the Royal Children’s Hospital’s Human Research and Ethics Department (HREC No 36031).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Will individual participant data be available (including data dictionaries)? Yes. What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification. What other documents will be available? Study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code. When will data be available (start and end dates)? Beginning 3 months and ending 5 years following article publication. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to firstname.lastname@example.org; to gain access, data requestors will need to sign a data access agreement.