29 Using Simulation in a Clinical Care Setting to Evaluate a Novel Medical Device with Families and Bedside Staff – Phase 1: Perceptions of the NeoVest under a Family Integrated Care (FICare) Model
Authors: Longmore Avery , Hollamby Kathleen , Zielonka Jeanne , Campbell Douglas M 
Published: August 2020

Abstract

Background
Newborn infants are at increased risk of requiring respiratory support with a mechanical ventilator. Nasal continuous positive airway pressure (nCPAP) is the most commonly used non-invasive respiratory support. Current nCPAP support is not synchronized to an infant’s breathing efforts, and can contribute to patient discomfort, skin breakdown, and interference with mother-infant bonding. An alternative to nCPAP is negative pressure ventilation. Our NeoVest was developed as a wearable vest that utilizes Neurally Adjusted Ventilator Assist (NAVA) technology to synchronize with the infant’s own respiratory drive and control. NeoVest and NAVA have demonstrated efficacy/feasibility in preliminary experiments emulating neonatal respiratory distress in animal models. Before implementation of this new technology in NICUs, it is important to assess the perspectives of NICU multi-disciplinary staff and parents to optimize design and understand its impact.

Objectives
The objective was to assess both clinicians’ and NICU parents’ perceptions of the NeoVest as compared with traditional nCPAP devices.

Design/Methods
Nurses, respiratory therapists and NICU parents at St. Michael’s Hospital in Toronto, Canada were invited to participate in the study. Research Ethics Board approval was obtained for this study. Parents were approached if their baby has previously been on CPAP. After consent, participants attended simulations that demonstrated the utility of the NeoVest. After the simulation, participants completed a survey that assessed their satisfaction and stress level regarding use of the NeoVest in a clinical setting. Numeric Likert scale responses and free text comments were collected from participants and analyzed. Free text comments were assessed using the principles of thematic analysis.

Results
Thirty clinicians (16 nurses, and 14 RTs), and 4 parents answered the survey. Almost all respondents were excited by the new technology and believed the use of simulation in the NICU was beneficial. Respondents reported that the NeoVest would not add stress to their roles in the NICU, and the majority of clinicians also believed that the NeoVest will improve care of the infant patient. Parents and clinicians both suggested that nCPAP can cause stress, and that the NeoVest would be preferred. One of the major themes regarding how the NeoVest may improve care from the perspective of both parents and clinicians was improved parent-child bonding through improved eye contact. Clinicians also believed it would reduce irritation, maintain skin integrity and have less complications as compared to nCPAP. The major themes with respect to clinician concerns about the NeoVest included: examining the neonate, umbilical line access, and the learning curve for new technology. The major themes with respect to parental concerns included: interference with skin to skin and holding their child.

Conclusion
Survey responses were overall favourable for introduction of new NICU technology, in this case a novel breathing device: the NeoVest. Although small, this cohort provided invaluable insight regarding the NeoVest’s impact on future patient populations. This highlights the importance of patient feedback in innovation. Next steps include a pilot study assessing the feasibility and efficacy of the NeoVest in the clinical setting, with re-administration of the questionnaires to compare reality and simulation.