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Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

NCT05961683 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-27

No results posted yet for this study

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

Interventions

DEVICE

NIV plus software

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Keck School of Medicine of USC

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-06-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961683 on ClinicalTrials.gov