Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483529
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-09-27
Brief Title:
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique an Explorative Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Respiratory failure has historically been one of the most important causes for admittance of patients to the critical care unit This problem was the most important reason during the COVID-19 pandemic Following the evolution of the physiology of the lung has therefore been the number one concern during these challenging times in the intensive care unit ICU Respiratory oscillometry RO identifies the lung impedance by applying small pressure oscillations onto the breathing or ventilation Information about the respiratory mechanics can be extracted out of this impedance including the resistance R and compliance C of the lung The VUB developed a robust patient safe RO measurement protocol that delivers high quality measurements with the least possible interference with the patients breathingventilation The technique challenges current state-of-the-art techniques also aiming at identifying R and C of the respiratory system not exclusively RO The RO measurement protocol is in line with the technical standards of the ERS European Respiratory Society and has been successfully and safely tested on emulators and some parts on test subjects The clinical investigation aims at a powered equivalence investigation between the RO measurement protocol and a standard of care dynamic compliance estimate on invasive ventilated patients As secondary objectives the feasibility of the RO techniques will be investigated during pressure support ventilation and the RO estimates will also be compared with other accepted respiratory mechanics estimation tools To enable the investigation a RO algorithm is developed and a RO measurement extension is implemented in the DemcAir ventilation system of Demcon This was a fully tested ventilator that received a CE mark under the previous MDD regulation However Demcon which produces ventilator parts for other commercial partners removed the label to avoid competition with their partners The ventilator will only execute the protocol on demand and save the data on an USB stick available in the ventilator At any time the RO measurement procedure can be stopped and the ventilator will return to its initial ventilation The USB stick is used to transport the data to a separate VUB laptop where the data processing is done
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None