Evangelische Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136, Germany
Location status: Recruiting
NCT Number: NCT06421181
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 ultrasound/echocardiography 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.
Interested in participating?
Request Info18 year and older
Female
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The heart rate will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The arterial blood pressures will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The stroke volume will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic feature of strain imaging for the analysis of contractile performance of the myocardium will be monitored prior to induction and after induction of anaesthesia to detect any changes
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic parameter will be monitored prior to induction and after induction of anaesthesia to detect any changes.
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes of the cardiac valve functions like increase of regurgitation
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The haemodynamic features will be monitored prior to the start of induction up to the end of induction of anaesthesia to detect any changes
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The ultrasound features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The MSFP will be determined based on the stop-flow-methodology to determine additionally venous return characteristics
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
BRS will be determined to analyse the impact of drugs of anaesthesia induction on the vegetative nervous system. The assessment is based on invasive measurement of the arterial blood pressure in combination with the electrocardiogram
Time frame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
Time frame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
Time frame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
Time frame: Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
The complications will be graded according to the "Clavien-Dindo" classification from one to five with one being a minor complication and five being death
Time frame: Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
The incidence of organ dysfunctions will be based on laboratory results and or pathophysiological features like delayed bowel opening after surgery
Contact information is provided by the study sponsor or research team.
Kliniken Essen-Mitte
Other
Acronym: KEM-HEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.