Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236685
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-28
First Post:
2024-01-24
Brief Title:
Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques AVIM
Sponsor:
Czech Technical University in Prague
Organization:
Czech Technical University in Prague
Study Overview
Official Title:
Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques
Status:
ENROLLING_BY_INVITATION
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:
AVIM
Brief Summary:
The aim of this study is to collect synchronized data from multiple monitoring techniques of mechanical ventilation pressureflow waves from the ventilator electrical impedance tomography - EIT esophageal pressure capnography in patients ventilated either on intensive care units or during anesthesia and evaluate the data by detailed mathematical analysis to test three hypotheses
1 Various published methods of calculation of the expiratory time constant provide different results in most cases
2 Inhomogeneous ventilation as described by EIT affects the form of the expiratory flow curve and thus the calculated expiratory time constants
3 The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver
This study does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician apart from extending the monitoring techniques
1 Various published methods of calculation of the expiratory time constant provide different results in most cases
2 Inhomogeneous ventilation as described by EIT affects the form of the expiratory flow curve and thus the calculated expiratory time constants
3 The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver
This study does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician apart from extending the monitoring techniques
Detailed Description:
Mechanical ventilation is known to cause various complications generally known as ventilator induced lung injury Thus detailed monitoring is essential However data interpretation is complicated in clinical practice The investigators aim to collect synchronized data from multiple monitoring techniques of mechanical ventilation pressureflow waves from the ventilator electrical impedance tomography - EIT esophageal pressure capnography in patients ventilated either on intensive care units or during anesthesia and evaluate the data by detailed mathematical analysis The results will be used to explore the complexity of seemingly simple and often used calculations describing the course of mechanical ventilation - mostly the expiratory time constant and amount of mechanical energy transferred to the lungs The investigators primarily aim to test three hypotheses
1 Various published methods of calculation of the expiratory time constant provide different results in most cases
2 Inhomogeneous ventilation as described by EIT affects the form of the expiratory flow curve and thus the calculated expiratory time constants
3 The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver
For this the investigators plan to recruit 50 patients undergoing general anesthesia with controlled mechanical ventilation and 50 patients hospitalized on intensive care units Monitoring of those patients will be protocolized and will in all cases include pressureflow monitoring of the mechanical ventilator capnography and electrical impedance tomography Esophageal pressure monitoring will be introduced where indicated by the clinician or where nasogastric tube insertion will be indicated as the pressure can be measured by a combined catheter
This study thus does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician apart from extending the monitoring techniques Patient data will be anonymized and all the enrolled patients or their families will sign an informed consent as agreed by the ethical committee of our hospital
1 Various published methods of calculation of the expiratory time constant provide different results in most cases
2 Inhomogeneous ventilation as described by EIT affects the form of the expiratory flow curve and thus the calculated expiratory time constants
3 The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver
For this the investigators plan to recruit 50 patients undergoing general anesthesia with controlled mechanical ventilation and 50 patients hospitalized on intensive care units Monitoring of those patients will be protocolized and will in all cases include pressureflow monitoring of the mechanical ventilator capnography and electrical impedance tomography Esophageal pressure monitoring will be introduced where indicated by the clinician or where nasogastric tube insertion will be indicated as the pressure can be measured by a combined catheter
This study thus does not test any new or non-standard methods and does not in any way interfere with the course of treatment indicated by the clinician apart from extending the monitoring techniques Patient data will be anonymized and all the enrolled patients or their families will sign an informed consent as agreed by the ethical committee of our hospital
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