NCT05512689

Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

Summary

This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.

Detailed description

The study was conducted at the Neonatal Intensive Care Unit and the delivery room at the Division of Neonatology, at the Medical University of Vienna. We aimed to record ventilation parameters (tidal volume, mask leak, ventilation rate, PIP, PEEP) using a CE-certified Respiratory Function Monitor (Neo100, Monivent AB, Gothenburg, Sweden), which was either hidden or visible to the provider responsible for the airway (airway provider), during ventilations on term and preterm patients at the NICU and the delivery room. The investigators aimed to determine the quality of ventilations performed by healthcare professionals depending on RFM visibility. Analysis occurred, determining whether observing the data displayed on the RFM during PPV of preterm and newborn infants lead to adjustments in applied pressure and an increase in the proportion of inflations performed within a predefined range of 4-8 ml/kg for VTe. The investigators hypothesized that using a RFM with numeric and graphical display of values during positive pressure ventilation of infants will lead to i) more frequent recognition and correction of tidal volumes outside the predefined range and ii) reduction of mask leak. This knowledge gain may improve future training using a RFM to improve the quality of ventilations and, thereby, patient safety.

Conditions

• Lung-protective Ventilation
• Respiratory Function Monitor

Interventions

Type	Name	Description
DEVICE	Ventilations while using a respiratory function monitor	Healthcare professionals are able to use a feedback device to guide their ventilations.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-08-23
• Last updated: 2023-11-22

Locations

1 site across 1 country: Austria