RESUMO
OBJECTIVE: The aim of this study was the evaluation of the impact of a respiratory function monitor (RFM, Neo100, Monivent AB, Gothenburg, Sweden) on the quality of ventilation in neonates. METHODS: This single-center two-phase intervention study was conducted at the Neonatal Intensive Care Unit and the delivery room of the Medical University of Vienna. Patients with clinical need for positive pressure ventilation were included in either of two consecutive study phases: (i) patients were ventilated with a hidden RFM (control) or (ii) visible RFM (intervention) during manual positive pressure ventilations. The duration of each phase was approximately six months. The primary outcome was the percentage of ventilations within a tidal volume range of 4-8 ml/kg (pVTe). RESULTS: A total of 90 patients (GA 22-66 weeks) were included. The primary outcome was significantly higher in the intervention group with a visible RFM (53.7%, SD 22.6) than in the control group without the monitor (37.3%, SD 20.5); (p < 0.001, mean difference [i.e., change in percentage points]: 16.95% CI: 7.4-35). In terms of secondary outcomes, excessive tidal volumes (>8ml/kg), potentially associated with an increased risk of brain injury, could be significantly reduced when a RFM was visible during ventilation (10.9% [IQR 26.4] vs. 29.5% [IQR 38.1]; p = 0.004). Furthermore, mask leakage could be significantly decreased (37.3% [SD 22.7] vs. 52.7% [SD 23.0]; p = 0.002). CONCLUSION: Our results suggest that the clinical application of a RFM for manual ventilation of preterm and term infants leads to a significant improvement in ventilation parameters.