Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

NCT05961683 | Unknown FDA Device

• 1 other identifier: 13192
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Distress Syndrome, Newborn; Apnea of Newborn

Outcome Measures

Primary Outcomes (1)

• interventions performed while using NIV plus software

  will study the number of interventions performed when NIV plus software is used

  24 hours

Secondary Outcomes (1)

• difference in pressures set and received

  12 hours

Study Arms (2)

Infants receiving non invasive ventilation without NIV plus

NO INTERVENTION

Infants receiving non invasive ventilation with NIV plus

EXPERIMENTAL

Device: NIV plus software

Interventions

NIV plus software DEVICE

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

Infants receiving non invasive ventilation with NIV plus

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keck School of Medicine of USC: lead
• Medtronic: collaborator

Study Sites (1)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Manoj Biniwale

CONTACT

3234093406; Biniwale@usc.edu

Rangasamy Ramanathan

CONTACT

3234093406; Ramanath@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)