Hemodynamic Effects of Anesthesia Induction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorKliniken Essen-Mitte
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte
Due to the invasiveness of the planned surgery there is an indication for an arterial and central-venous line as well as an peridural catheter
Disqualifiers
Age < 18 years
Lack of written informed consent
Insufficient language skills
Unwillingness to have pseudonymized disease data stored at the study site and lack of consent to share anonymized data as part of the clinical trial
Trial population
Patients with the diagnosis of advanced primary ovarian cancer will be screened prior to cytoreductive surgery in cooperation with the colleagues of gynaecological oncology. If the patients are eligible they will be informed to give consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia
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 hours2
Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia
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 hours3
Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia
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 hours4
Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia
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 hoursSecondary outcomes
1
Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium
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 hours2
Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography
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 hours3
Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography
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 hours4
Changes of function of the cardiac valves assessed by a transthoracic echocardiography
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 hoursOther outcomes
1
Examination times of the echocardiographic assessment by a not-certified expert
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 hours2
Implementation rates in percentages of the echocardiographic assessment by a not-certified expert during clinical care
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 hours3
Number of missed diagnositics of the echocardiographic assessment by a not-certified expert vs. an assessment by a certified examiner
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 hours4
Incidence and description of postoperative complications
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Kliniken Essen-Mitte
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborator
Source ClinicalTrials.gov