Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Study Overview
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Brief Summary
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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

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

Conditions
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Respiratory Distress Syndrome, Newborn, Apnea of Newborn

Intervention / Treatment
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* Device: NIV plus software


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Infants receiving non invasive ventilation without NIV plus<br> | |
| Experimental: Infants receiving non invasive ventilation with NIV plus<br> | Device: NIV plus software<br>* interventions received by infants studied after placing them on ventilator using NIV plus software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interventions performed while using NIV plus software | will study the number of interventions performed when NIV plus software is used | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in pressures set and received | will study the pressure difference as calculated by NIV plus software | 12 hours |