NCT04659083

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Inha University Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 36 Weeks
• Healthy volunteers: Accepted

Summary

For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period. The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.

Conditions

• Premature Infants
• Neurally Adjusted Ventilatory Assist
• Ventilator Lung; Newborn
• Mechanical Ventilation

Interventions

Type	Name	Description
DEVICE	Neurally adjusted ventilatory assist ventilation mode	This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-12-09
• Last updated: 2021-01-12

Locations

1 site across 1 country: Finland