Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-09-30

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

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn Apnea of Newborn

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infants receiving non invasive ventilation without NIV plus

Group Type NO_INTERVENTION

No interventions assigned to this group

Infants receiving non invasive ventilation with NIV plus

Group Type EXPERIMENTAL

NIV plus software

Intervention Type DEVICE

interventions received by infants studied after placing them on ventilator using NIV plus software

Interventions

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NIV plus software

interventions received by infants studied after placing them on ventilator using NIV plus software

Intervention Type DEVICE

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

Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No