Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421181
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-26
Brief Title:
Hemodynamic Effects of Anesthesia Induction
Sponsor:
Kliniken Essen-Mitte
Organization:
Kliniken Essen-Mitte
Study Overview
Official Title:
Hemodynamic Effects of Anesthesia Induction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
KEM-HEN
Brief Summary:
The idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention induction of anesthesia in a highly controlled environment by two hemodynamic monitoring devices The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion
Both devices complement one another in their hemodynamic profiling ability One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasoundechocardiography device with advanced possibilities for differential diagnostics
A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert
Both devices complement one another in their hemodynamic profiling ability One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasoundechocardiography device with advanced possibilities for differential diagnostics
A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert
Detailed Description:
Mortality after surgery is still high and high-risk procedures are associated to high postoperative complication rates For hemodynamic monitoring a meta-analysis showed a reduction in mortality and especially for the esophageal Doppler a reduction in postoperative complications However the effects reducing mortality and morbidity have to be considered as low Probably this is the reason why daily clinical implementation rates of hemodynamic monitoring are low too
However hemodynamic studies only focus on intraoperative optimization but recent publications suggested that taking preoperative individual hemodynamic values for arterial blood pressure and cardiac index as targets for optimization provides advanced therapeutic options Lastly both studies do not provide data about the preoperative values and their changes during the induction of anesthesia
Our own data confirm that the induction of anesthesia the establishment of a working epidural and the surgical incision of the abdomen leads to decreased cardiac index and markers of inotropy in otherwise cardiovascular healthy patients However the intervention studies and our own data strongly suggest that starting hemodynamic monitoring after the induction of anesthesia or the surgical incision may foreclose that the clinician can guide the hemodynamic therapy towards individualized goals Additionally the corrective treatment in this scenario could be different from just vasopressors
Nevertheless in contrast to our own data a recent study showed that hypotension in the post-induction period is primarily associated with a decreased vascular tone due to anesthetic agents suggesting that the appropriate treatment is vasopressors
A detailed hemodynamic profiling of non-cardiac patients undergoing high-risk cancer surgery prior during and after the induction of anaesthesia may provide new insights about the effects of anaesthetic drugs positive pressure ventilation and changes of sympathetic tone
However hemodynamic studies only focus on intraoperative optimization but recent publications suggested that taking preoperative individual hemodynamic values for arterial blood pressure and cardiac index as targets for optimization provides advanced therapeutic options Lastly both studies do not provide data about the preoperative values and their changes during the induction of anesthesia
Our own data confirm that the induction of anesthesia the establishment of a working epidural and the surgical incision of the abdomen leads to decreased cardiac index and markers of inotropy in otherwise cardiovascular healthy patients However the intervention studies and our own data strongly suggest that starting hemodynamic monitoring after the induction of anesthesia or the surgical incision may foreclose that the clinician can guide the hemodynamic therapy towards individualized goals Additionally the corrective treatment in this scenario could be different from just vasopressors
Nevertheless in contrast to our own data a recent study showed that hypotension in the post-induction period is primarily associated with a decreased vascular tone due to anesthetic agents suggesting that the appropriate treatment is vasopressors
A detailed hemodynamic profiling of non-cardiac patients undergoing high-risk cancer surgery prior during and after the induction of anaesthesia may provide new insights about the effects of anaesthetic drugs positive pressure ventilation and changes of sympathetic tone
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