Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03168126
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-05-24
Brief Title:
Advanced Hemodynamic Monitoring in Free Flap Surgery
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Advanced Hemodynamic Monitoring in Free Flap Surgery
Status:
COMPLETED
Status Verified Date:
2017-05
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:
AHM
Brief Summary:
Background Anesthesia in free flap surgery is challenging Monitoring of hemodynamic changes and their influence on the cardiovascular system in permanent feedback loops allow control which is what anesthesiologists aim for to ensure an adequate blood flow and tissue oxygenation The circulatory support and inferable volume administration are managed via heart rate HR and mean arterial pressure MAP but both parameters are influenced by variable components and are thus unfavorable for volume management The aim of this study was to evaluate whether volume requirement may be assumable to additional monitoring parameters
Methods 31 patients were enrolled prospectively HR MAP central venous pressure and O2 saturation were comprehended based on the protocols We expanded the data set by a permanent blinded intraoperative monitoring with registration of the Cardiac Index CI and Stroke Volume Variation SVV and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device
Methods 31 patients were enrolled prospectively HR MAP central venous pressure and O2 saturation were comprehended based on the protocols We expanded the data set by a permanent blinded intraoperative monitoring with registration of the Cardiac Index CI and Stroke Volume Variation SVV and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device
Detailed Description:
We conducted a prospective cohort study in accordance with the WMA Declaration of Helsinki Standard general anesthesia with intubation and administration of sufentanil propofol and esmeron relaxant was performed in all patients undergoing primary free flap reconstruction in course of a head and neck tumor reconstruction Hemodynamic monitoring measurement of cardiac index and the parameter stroke volume variation as surrogate for cardiac pre-load was performed using a Pro-AQT Monitor Using an arterial catheter previously set by the Seldinger technique as part of the standard equipment the mean diastolic and systolic arterial pressure was measured as part of the standard monitoring as presented This tube was previously deaerated and flushed with 2 NaCl and connected in series with a sensor which passes over electric line signals to the Pro-AQT-Monitor Based on previously entered patient data and an analysis of the arterial pulse curve characteristics a cardiac index CI start-value is determined by the system The sampling of the arterial pressure characteristics is affected by a signal having a frequency of 250 Hz The start value is the basis for the further determination of HI trend values The arterial pulse contour is continuously tapped and analyzed and offset against the determined start value To calculate the cardiac index the PICCO-pulse contour algorithm is applied Every 12 seconds a new measurement is performed and documented by the system
From the read logs ProAQT Monitor the values of the CI MAP HR stroke volume index SVI the stroke volume variation SVV and the systemic resistance index SRI were recorded at different measurement intervals throughout the operation All parameters were evaluated for volume control in the course of the study
From the read logs ProAQT Monitor the values of the CI MAP HR stroke volume index SVI the stroke volume variation SVV and the systemic resistance index SRI were recorded at different measurement intervals throughout the operation All parameters were evaluated for volume control in the course of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None