Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961683
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-18
Brief Title:
Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
Sponsor:
Keck School of Medicine of USC
Organization:
Keck School of Medicine of USC
Study Overview
Official Title:
Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None