Clinical trial NCT06421181: Hemodynamic Effects of Anesthesia Induction
Official title: Hemodynamic Effects of Anesthesia Induction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Undergoing Anaesthesia Induction
Keywords: Hemodynamic monitoring
Point-of-care ultrasound
Point-of-care echocardiography
Anaesthesia induction
Respiratory effects
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2024-05-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Secondary outcomes:
measure: Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Changes of function of the cardiac valves assessed by a transthoracic echocardiography
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: 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
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Mean systemic filling pressure (MSFP)
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
measure: Baroreceptor sensitivity (BRS)
timeFrame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Other outcomes:
measure: Examination times of the echocardiographic assessment by a not-certified expert
timeFrame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
measure: Implementation rates in percentages of the echocardiographic assessment by a not-certified expert during clinical care
timeFrame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
measure: Number of missed diagnositics of the echocardiographic assessment by a not-certified expert vs. an assessment by a certified examiner
timeFrame: Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
measure: Incidence and description of postoperative complications
timeFrame: Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
measure: Incidence and description of postoperative organ dysfunctions
timeFrame: Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
Locations:
city: Essen
country: Germany
facility: Evangelische Kliniken Essen-Mitte
state: NRW
Study officials:
affiliation: Evangelische Kliniken Essen-Mitte
name: Aarne Feldheiser, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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