Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Not Applicable

Not yet recruiting

• Conditions: Apnea of Newborn; Respiratory Distress Syndrome, Newborn
• Interventions: Device: NIV plus software

• Registration Number: NCT05961683
• Lead Sponsor: Keck School of Medicine of USC

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-08-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infants receiving non invasive ventilation with NIV plus	NIV plus software	-

Primary Outcome Measures

Name	Time	Method
interventions performed while using NIV plus software	24 hours	will study the number of interventions performed when NIV plus software is used

Secondary Outcome Measures

Name	Time	Method
difference in pressures set and received	12 hours	will study the pressure difference as calculated by NIV plus software

Trial Locations

Locations (1)

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States