Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004206
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-08-09
Brief Title:
Patient-ventilator Interaction During NIV With Helmet a Comparison Between PSV and the New NIV NPS Software
Sponsor:
ASL Novara
Organization:
ASL Novara
Study Overview
Official Title:
Patient-ventilator Interaction During NIV With Helmet a Comparison Between PSV and the New NIV NPS Software
Status:
COMPLETED
Status Verified Date:
2024-01
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:
The goal of this clinical trial is to evaluate if neural pressure support ventilation is able to improve patient-ventilator synchrony in ICU patients undergoing non-invasive ventilation NIV The main question it aims to answer is
Is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet NIV
Researchers will compare neural pressure support ventilation versus pressure support ventilation Gold standard assisted mode in Europe to see if the new mode improve patient-ventilator synchrony
Is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet NIV
Researchers will compare neural pressure support ventilation versus pressure support ventilation Gold standard assisted mode in Europe to see if the new mode improve patient-ventilator synchrony
Detailed Description:
Non-Invasive Ventilation NIV has found many different uses in clinical settings shortening intubation times and preventing orotracheal intubation NIV success is highly affected by patient comfort and patient-ventilator synchrony The helmet is one of the most comfortable interfaces even if synchrony is low due to dead space The use of Neurally Adjusted Ventilatory Assist NAVA in which the Electrical Activity of the Diaphragm EAdi drives the ventilator has shown improvement in comfort and synchrony but still some limitation with helmet due to the long pressurization time Pressure-Support Ventilation PSV is still the most used and diffused assisted mode in Europe due to its simplicity and effectiveness in helmet-NIV The aim of this study is to test a new ventilation software called Neural Pressure Support Ventilation nPSV which merges the rapid pressurization of PSV along with the EAdi trigger onto a population of 24 critical care patients ventilated with a helmet NIV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None