RACer-PAP. Investigating the utility and acceptability of a new non-invasive ventilatory assist device, during exercise, in a population of normal, healthy adults: A feasibility study. (Preprint)

BACKGROUND Non-Invasive Ventilation (NIV) has been demonstrated to benefit people who have moderate to severe COPD during acute exacerbations. Studies have begun to investigate the effectiveness of NIV during pulmonary rehabilitation (PR) to improve outcomes for people with COPD, however the lack of portability and humidification of these devices means the use of such devices is limited, especially when performing activities of daily living. A new prototype device, RACer-PAP, delivers battery-operated positive airway pressure via a nasal interface whilst regulating nasal airway apportionment bias, removing the need for supplementary humidification. This device may offer people with COPD an improved ability to participate in PR and activities of daily living. OBJECTIVE To assess the feasibility of exercising with the RACer-PAP in situ and the acceptability of the device during exercise in normal, healthy individuals. METHODS 15 healthy adults were invited to attend two exercise sessions, one week apart, to assess baseline 6-minute walk distance (6MWD) with and without the RACer-PAP in situ. Vital signs and spirometry were monitored throughout, and spirometry was taken pre and post RACer-PAP testing. Subjective questionnaires ascertained participant feedback on exercising with the device in situ. RESULTS 14 (93%) participants completed both sessions. There were no adverse events associated with exercising with the device in situ. There were no differences in vital signs and 6MWD whether exercising with or without the device in situ. There were small increases in maximum dyspnoea scores (on Borg scale) on exercise with the device in situ compared with no device on exercise (median/IQR: 2.0/0.5-3.0 vs 3.0/2.0-3.25). There were small increases in forced vital capacity following exercise with the RACer-PAP. None of the participants reported symptoms associated with airway drying. Participant feedback provided recommendations for modifications for the next iteration of the device, prior to piloting the device with people with COPD. CONCLUSIONS This study has shown RACer-PAP to be safe and feasible to use during exercise and has provided feedback for modifications to the device to improve its use during exercise. We now propose to consider the application of the device in a small pilot feasibility study to assess safety, feasibility and utility of the device in a population of people with moderate to severe COPD. CLINICALTRIAL The study was prospectively registered and approved on ACTRN12619000478112 on 22/03/2019.