A randomised controlled trial of the use of a respiratory function monitor to teach neonatal mask ventilation to healthcare professionals in a simulation setting

Training in mask ventilation will be conducted according to the Newborn Resuscitation (NeoResus) program with the addition of a Respiratory Function Monitor (RFM) attached to the t- piece device (Neopuff). This will provide continuous real time feedback on mask leak. Course participants will perform the mask ventilation skill station in groups of six. Neonatal mask ventilation training will last for 1 hour and 25 minutes in total. During this time period each participant will perform two episodes of mask ventilation, each lasting 90 seconds. The first episode will consist of the participant performing mask ventilation as a standalone skill. The second episode will consist of the participant performing mask ventilation as part of a simulated resuscitation scenario. Participants will be instructed on mask ventilation and on interpretation of the RFM. When performing mask ventilation, the participants will be instructed to achieve: 1. Minimal (0-10%) mask leak, and 2. Mannequin chest rise Both the participants and trainers will observe leak and chest rise during ventilation. Participants will adjust their technique to minimise the leak by making the following changes: 1. Reposition airway to the neutral position, avoid neck flexion or overextension 2. Mask adjustment: adjust face mask hold, ensure face mask is covering nose and mouth, ensure mask is pressed against mannequin face, adjust face mask position on face, reapply face mask Participants will be advised of additional manoeuvers (suction mouth and nose, open mouth, increase pressure, consider an alternative airway) to attempt if they are unable to obtain chest rise and improvement in heart rate/colour and saturations in the simulation setting. Quality assurance: Supervision; Each training course is supervised by 3-4 Nurse educators and 1-2 medical educators (Neonatal fellow and neonatal consultant or two neonatal fellows) Measurement of participant adherence and compliance to teaching protocol; Compliance with the standardisation of training and instruction will be ensured by facilitator instruction pre-course, assessment of facilitators, the use of checklists to assist facilitators, intermittent reassessment of each facilitator (6 monthly) and the presence of an independent researcher at each station, who is responsible for compliance with the study protocol i.e. timing of intervention, clarity and order of instruction. Compliance with the protocol will be recorded in each participant CRF. Significant non-compliance is defined as a participant failing to perform two episodes of mask ventilation or performed mask ventilation for under 50% of the allocated time. Facilitators and researchers will be advised to report each incidence of significant non-compliance to the PI. A high number of non-compliance incidents will trigger a protocol review. Assessment: Immediately after the skill session, participants will be reassessed and mask leak will be recorded for 90 seconds of mask ventilation. This timeframe was chosen because international guidelines recommend operators re-assess the airway every 30 seconds and we wish to capture at least 2 reassessment episodes.