Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Keck School of Medicine of USC

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome, Newborn; Apnea of Newborn

Treatments: Device: NIV plus software

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05961683

13192

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestation Age of 23-41 weeks
• Born at LAC+USC Medical Center and admitted to NICU
• Received NIPPV or nasal CPAP

Exclusion criteria

• Infants with any congenital anomalies
• Infants receiving only comfort care measures.
• Infants receiving invasive mode of mechanical ventilation (intubated)
• Non-inborn neonates
• Re-admissions to the NICU

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Infants receiving non invasive ventilation without NIV plus

No Intervention group

Infants receiving non invasive ventilation with NIV plus

Experimental group

Treatment:

Device: NIV plus software