Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

July 18, 2023 updated by: Manoj Biniwale, Keck School of Medicine of USC

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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
Experimental: Infants receiving non invasive ventilation with NIV plus
Device: NIV plus software
interventions received by infants studied after placing them on ventilator using NIV plus software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interventions performed while using NIV plus software
Time Frame: 24 hours
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
Time Frame: 12 hours
will study the pressure difference as calculated by NIV plus software
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keck School of Medicine of USC

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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