Actively Recruiting

Age: 18Years +
FEMALE
ID06421181

Hemodynamic Effects of Anesthesia Induction Observational Study Using Advanced Heart Monitoring Devices

Led by Kliniken Essen-Mitte · Updated on 2025-01-15

30

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

Sponsors

K

Kliniken Essen-Mitte

Lead Sponsor

H

Heinrich-Heine University, Duesseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of anesthesia induction on heart and blood flow functions in patients undergoing elective laparotomy surgery. This study aims to better understand how anesthesia affects heart rate, blood pressure, stroke volume, and heart muscle function in a controlled clinical setting. It also explores the use of two hemodynamic monitoring devices, one providing continuous data and the other using advanced ultrasound imaging, to profile these changes in detail. The study uses two complementary devices for monitoring hemodynamic changes during anesthesia induction. One device continuously tracks changes with instant feedback, while the other provides advanced echocardiography for detailed diagnostics. Additionally, the study tests whether non-expert anesthetists can perform comprehensive echocardiographic analyses using a device with artificial intelligence support, comparing their results to those of certified experts. Participants will be closely monitored from the start of anesthesia induction until the beginning of surgery, up to four hours. Researchers will measure changes in heart rate, blood pressure, stroke volume, and myocardial strain using echocardiography. Data collection includes continuous monitoring and periodic ultrasound evaluations. The study focuses on safety, quality of monitoring, and the ability to detect flow pattern changes, aiming to improve personalized hemodynamic management during surgery.

CONDITIONS

Official Title

Hemodynamic Effects of Anesthesia Induction

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte
  • Indication for arterial and central-venous line and peridural catheter due to surgery invasiveness
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Lack of written informed consent
  • Insufficient language skills
  • Unwillingness to have pseudonymized disease data stored or anonymized data shared
  • American Society of Anesthesiologists physical status higher than grade 3
  • Congestive heart failure grade 2 or higher according to the New York Heart Association
  • Ischemic cardiopathy grade 2 or higher according to the Canadian Cardiovascular Society
  • Known severe heart valve diseases
  • Chronic kidney disease requiring hemodialysis
  • Atrial fibrillation or atrial flutter
  • Pulmonary hypertension

AI-Screening

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Trial Site Locations

Total: 1 location

1

Evangelische Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany, 45136

Actively Recruiting

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Research Team

A

Aarne Feldheiser, M.D., PhD.

S

Stefan Boland

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis.

Matthew A Chong, Yongjun Wang, Nicolas M Berbenetz...

https://pubmed.ncbi.nlm.nih.gov/29369117

Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis.

J Ripollés-Melchor, R Casans-Francés, A Espinosa...

https://pubmed.ncbi.nlm.nih.gov/26873025

Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery.

Daniel I Sessler, Joshua A Bloomstone, Solomon Aronson...

https://pubmed.ncbi.nlm.nih.gov/30916004

Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial.

Karim Kouz, Mirja Wegge, Moritz Flick...

https://pubmed.ncbi.nlm.nih.gov/36008202

Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.

Emmanuel Futier, Jean-Yves Lefrant, Pierre-Gregoire Guinot...

https://pubmed.ncbi.nlm.nih.gov/28973220

Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial.

Julia Y Nicklas, Oliver Diener, Maximilian Leistenschneider...

https://pubmed.ncbi.nlm.nih.gov/32711724

Mechanisms contributing to hypotension after anesthetic induction with sufentanil, propofol, and rocuronium: a prospective observational study.

Bernd Saugel, Elisa-Johanna Bebert, Luisa Briesenick...

https://pubmed.ncbi.nlm.nih.gov/33523352

Perioperative advanced haemodynamic monitoring of patients undergoing multivisceral debulking surgery: an observational pilot study.

Charlotte Middel, Matthias Stetzuhn, Nadine Sander...

https://pubmed.ncbi.nlm.nih.gov/37682496