Objectives To assess the feasibility and tolerance of NeuroPAP, a new non-invasive ventilation mode which continuously adjusts (during both inspiration and expiration) the pressure support proportionally to the diaphragm electrical activity (Edi), in preterm infants and to evaluate the impact on ventilation pressure and Edi.
Design Prospective cross-over single-centre feasibility study.
Setting One level 3 neonatal intensive care unit in Canada.
Patients Stable preterm infants ventilated with non-invasive positive pressure ventilation (NIPPV).
Interventions Subjects were successively ventilated in NIPPV with prestudy settings (30 min), in NeuroPAP with minimal pressure similar to NIPPV PEEP (positive end-expiratory pressure) (60 min), in NeuroPAP with minimal pressure reduced by 2 cmH20 (60 min), in continuous positive airway pressure (15 min) and again in NIPPV (30 min). Main outcome measures included tolerance, ventilation pressure, Edi and patient-ventilator synchrony.
Results Twenty infants born at 28.0±1.0 weeks were included. NeuroPAP was well tolerated and could be delivered during 100% of planned period. During NeuroPAP, the PEEP was continuously adjusted proportionally to tonic diaphragm Edi, although the average PEEP value was similar to the set minimal pressure. During NeuroPAP, 83 (78–86)% breaths were well synchronised vs 9 (6–12)% breaths during NIPPV (p<0.001).
Conclusions NeuroPAP is feasible and well tolerated in stable preterm infants, and it allows transient adaptation in PEEP in response to tonic diaphragm electrical activity changes. Further studies are warranted to determine the impact of these findings on clinical outcomes.
Trial registration number NCT02480205.
- intensive Care
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Contributors M-ER participated in data acquisition and data analysis, participated in the initial manuscript draft and reviewed and revised the manuscript. GL and SE contributed in the study conceptualisation, in the data acquisition and analysis and reviewed and revised the manuscript. LT contributed in the data analysis and manuscript preparation. SM contributed in the study preparation and in the data acquisition and reviewed the manuscript. CS and JB contributed in the study conceptualisation, in the data analysis and reviewed and revised the manuscript. GE conceptualised and designed the study, contributed in data acquisition, supervised the data analysis, drafted the initial manuscript and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding Maquet Critical Care provided the ventilator and catheters for the study and reimbursed the costs associated with the preparation and conduct of the study.
Disclaimer Maquet Critical Care was not involved in the results analysis or reporting.
Competing interests GE’s research programme is supported by a scholarship award by the Fonds de Recherche du Québec—Santé. JB and CS have made inventions related to neural control of mechanical ventilation that are patented. The patents are assigned to the academic institution(s) where inventions were made. The licence for these patents belongs to Maquet Critical Care. Future commercial uses of this technology may provide financial benefit to JB and CS through royalties. JB and CS each own 50% of Neurovent Research Inc (NVR). NVR is a research and development company that builds the equipment and catheters for research studies. NVR has a consulting agreement with Maquet Critical Care. The remaining authors have no conflicts of interest to disclose.
Patient consent for publication Not required.
Ethics approval The study was approved by the local Research Ethics Committee (#4083). We obtained a written informed parental consent prior enrolment.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. All recorded data are available for scientific work, providing a research collaboration agreement is concluded with the principal investigators and after approval by the research ethics committee and Maquet Critical Care.
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