Patients Undergoing Anaesthesia Induction
Conditions
Keywords
Hemodynamic monitoring, Point-of-care ultrasound, Point-of-care echocardiography, Anaesthesia induction, Respiratory effects
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 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.
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.
Interventions
None listed
Sponsors
Heinrich-Heine University, Duesseldorf
Kliniken Essen-Mitte
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * American society of anaesthesiologists physical status higher as grade 3 * congestive heart failure with a grade of 2 or higher according to the New York heart association (NYHA) * Ischemic cardiopathy with a grade of 2 or higher according to the Canadian cardiovascular society (CCS) * Known severe valve pathologies of the heart * Chronic kidney disease with dependency of hemodialysis * Atrial fibrillation ora trail flutter * Pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia | 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. |
| Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia | 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 |
| Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia | 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. |
| Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of function of the cardiac valves assessed by a transthoracic echocardiography | 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 |
| Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium | 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 |
| Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography | 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. |
| Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography | 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 |
| Changes in percentage of the cardiocirculatory flow in an advanced hemodynamic monitoring device based on a pulse-contour methodology in a continuous fashion during induction of anaesthesia | 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 |
| Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound | 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 |
| Mean systemic filling pressure (MSFP) | 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 |
| Baroreceptor sensitivity (BRS) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation rates in percentages of the echocardiographic assessment by a not-certified expert during clinical care | 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 |
| Examination times of the echocardiographic assessment by a not-certified expert | 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 |
| Incidence and description of postoperative organ dysfunctions | 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 |
| Incidence and description of postoperative complications | 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 |
| Number of missed diagnositics of the echocardiographic assessment by a not-certified expert vs. an assessment by a certified examiner | 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 |
Countries
Germany
Contacts
Primary ContactAarne Feldheiser, M.D., PhD.
Backup ContactStefan Boland
Outcome results
None listed