NCT05961683

Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Keck School of Medicine of USC · Academic / Other
• Sex: All
• Age: 0 Days – 30 Days
• Healthy volunteers: Not accepted

Summary

In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU

Conditions

• Respiratory Distress Syndrome, Newborn
• Apnea of Newborn

Interventions

Type	Name	Description
DEVICE	NIV plus software	interventions received by infants studied after placing them on ventilator using NIV plus software

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study