RecruitingACTRN12625001100482

Assessing the use of the Juno Monitor on mask leak during Neonatal Resuscitation Training

Assessing the use of the Juno Monitor on mask leak during Neonatal Resuscitation Training of non-specialist healthcare professionals

Sponsor

Perth Children's Hospital

Enrollment

60 participants

Start Date

Apr 11, 2025

Study Type

Interventional

Conditions

Prematurity Neonatal resuscitation

Summary

Background: Transition to breathing at birth is dependent on sufficient entry of air into the lungs and is the cornerstone of neonatal resuscitation. For the 5-10% of babies that require assistance at birth, the equipment used includes a self-inflating bag or pressure limited flow regulator. Good mask technique is essential to reduce leak and provide effective ventilation. In preterm resuscitation, the rate of respiration and tidal volume delivered are also key in reducing air leak and protecting against volutrauma to the preterm lung. Newborn resuscitation training performed on preterm mannequins relies on the visual feedback from instructors on chest rise and fall. The JUNO respiratory function monitor is an in-line device that serves as a training aid. It provides real-time feedback on percentage of leak, respiratory rate and tidal volume delivered with each breath administered. There is emerging evidence of its utility in the training of neonatal resuscitation within the neonatal community. This study aims to assess its effectiveness in reducing facemask leak within the non-specialist community. Objectives: The aim of this project is to assess whether the Juno Training Monitor is superior to current training methods at reducing mask leak during neonatal resuscitation within the non-neonatal specialist community. Project Plan: Candidates attending a neonatal stabilisation course will be randomised to either facemask ventilation training with real-time feedback from the JUNO training monitor, or to standard training. A 30-second simulation post-training with the monitor blinded will then be performed. The primary outcome will be the amount of time spent with a mask lead <30%. Secondary outcomes will include the rate of respiration and tidal volume administered.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a newborn baby needs help breathing at birth, the most critical skill is making sure the face mask used during resuscitation creates a proper seal so air can enter the lungs. Even small leaks can mean the baby does not get enough oxygen. This study is testing whether a real-time feedback device called the Juno Monitor — which shows practitioners exactly how much air is leaking, how fast they are breathing for the baby, and how much air is being delivered — can help non-specialist healthcare workers learn better mask technique. Healthcare professionals attending a neonatal stabilisation training course will be randomly assigned to practise on a newborn mannequin either with or without the Juno Monitor providing live feedback. Afterwards, everyone will complete a short simulation with the monitor hidden, so researchers can measure skill levels fairly. You may be eligible if you are a healthcare professional (but not a specialist neonatologist) attending a NeoStars neonatal stabilisation and resuscitation course and are willing to give consent to participate.

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Interventions

Training will be delivered on a premature mannequin (Lifecast Body Simulation Ltd, London, UK) will be used, which resembles a 28-week gestation newborn. Ventilation will be delivered using a small size Fisher and Paycal (Auckland, New Zealand) facemask and T-piece resuscitaire (Neopuff, Fisher & Paykel Healthcare, Auckland, New Zealand) with settings of 8l/min gas flow, Peak Inspiratory Pressure (PIP) 25cmH20 and Peak End Expiratory Pressure (PEEP) 5cmH20, which are standard settings for a preterm newborn. Intervention arm will receive the JUNO training device. In the intervention group each healthcare professional (HCP) will be demonstrated standard facemask technique. Training will be delivered by a Neonatologist from the Newborn Emergency Transfer Service of Western Australia (NETS-WA). The facilitator will assist the HCP to achieve good chest rise determined via visual inspection. In addition to this standard training, the intervention group will receive Juno monitor training. During the Juno monitor training, the “training mode” will be displayed to give real-time feedback. The facilitator will use this information to assist the HCP until “no leak” has been achieved, as well as achieving appropriate volumes and respiratory rates for the estimated weight of the baby. The Juno training monitor (ResusRight™, Sydney, Australia) has been designed specifically for education. This device fits in-line to a self-inflating bag or pressure limited flow regulator. It provides real time feedback on leak percentage, tidal volume and respiratory rate. Training will be delivered in a group format to between 8-10 participants at a time. Each participant will then have the opportunity to practice with the Juno monitor one-on-one during the airway station of the NeoStars course which is 45-minutes in duration.