Hemodynamic Effects of Anesthesia Induction

NCT06421181 | Recruiting

• 1 other identifier: KEM-HEN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Anaesthesia Induction

Keywords

Hemodynamic monitoring; Point-of-care ultrasound; Point-of-care echocardiography; Anaesthesia induction; Respiratory effects

Outcome Measures

Primary Outcomes (4)

• 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 from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours

• 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 from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours

• 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 from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours

• 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 from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours

Secondary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (5)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Evangelische Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Related Publications (9)

• Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.

  PMID: 29369117 BACKGROUND

• Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish.

  PMID: 26873025 BACKGROUND

• Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.

  PMID: 30916004 BACKGROUND

• Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.

  PMID: 36008202 BACKGROUND

• Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

  PMID: 28973220 BACKGROUND

• Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094.

  PMID: 32711724 BACKGROUND

• Saugel B, Bebert EJ, Briesenick L, Hoppe P, Greiwe G, Yang D, Ma C, Mascha EJ, Sessler DI, Rogge DE. Mechanisms contributing to hypotension after anesthetic induction with sufentanil, propofol, and rocuronium: a prospective observational study. J Clin Monit Comput. 2022 Apr;36(2):341-347. doi: 10.1007/s10877-021-00653-9. Epub 2021 Feb 1.

  PMID: 33523352 BACKGROUND

• Middel C, Stetzuhn M, Sander N, Kalkbrenner B, Tigges T, Pielmus AG, Spies C, Pietzner K, Klum M, von Haefen C, Hunsicker O, Sehouli J, Konietschke F, Feldheiser A. Perioperative advanced haemodynamic monitoring of patients undergoing multivisceral debulking surgery: an observational pilot study. Intensive Care Med Exp. 2023 Sep 8;11(1):61. doi: 10.1186/s40635-023-00543-1.

  PMID: 37682496 RESULT

• Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.

  PMID: 37265333 RESULT

Study Officials

• Aarne Feldheiser, M.D., PhD.

  Evangelische Kliniken Essen-Mitte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aarne Feldheiser, M.D., PhD.

CONTACT

+49201174; a.feldheiser@kem-med.com

Stefan Boland

CONTACT

+49201174; s.boland@kem-med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 20, 2024
• Study Start: January 14, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)