Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Sponsor

Keck School of Medicine of USC (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05961683

Collaborator

Medtronic (Industry)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn Apnea of Newborn	Device: NIV plus software	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

difference in pressures set and received [12 hours]
will study the pressure difference as calculated by NIV plus software

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles General Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

Keck School of Medicine of USC
Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manoj Biniwale, Associate Professor of Pediatrics, Keck School of Medicine of USC

ClinicalTrials.gov Identifier:

NCT05961683

Other Study ID Numbers:

13192

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Jul 27, 2023