RecruitingNot ApplicableNCT06247384

The Hypotension Prediction Index in Major Abdominal Surgery

The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.


Sponsor

Jakub Szrama

Enrollment

226 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery. Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index. The main question the study aims to answer is: • will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of \>15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
  • Patients with American Society of Anesthesiologists (ASA) status III or IV.
  • Written informed consent.

Exclusion Criteria5

  • Patients under 18 years
  • Lack of health insurance
  • Pregnancy
  • Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \< 35 %
  • Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring

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Interventions

DEVICEHypotension Prediction Index Hemodynamic Monitoring

The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.


Locations(1)

Department of Anesthesiology, Intensive Therapy and Pain Management

Poznan, Poznań, Poland

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NCT06247384


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