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.
The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
226
The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, Poland
RECRUITINGTime weighed average of hypotension below 65 mmHg
depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypotension below 50 mmHg
depth of hypotension in millimetres of mercury below a MAP of 50 mmHg x time in minutes spent below MAP of 50 mmHg)/total duration of operation in minutes
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 90 mmHg
rise of hypertension in millimetres of mercury above a MAP of 90 mmHg x time in minutes spent above MAP of 90 mmHg)/total duration of operation in minutes
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 100 mmHg
rise of hypertension in millimetres of mercury above MAP of 100 mmHg x time in minutes spent above MAP of 100 mmHg)/total duration of operation in minutes
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
30 day mortality
30 day mortality
Time frame: 30 consecutive days starting from the day of the surgery
Length of hospitalisation
Length of hospitalisation
Time frame: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days
Myocardial injury evaluated by postoperative troponin levels
Myocardial injury evaluated by postoperative troponin levels
Time frame: First, second and fifth postoperative day
Kidney injury evaluated by creatinine levels
Kidney injury evaluated by creatinine levels (increase in sCr by ≥0.3 mg/dL within 48 hours; increase in sCr to 1.5 times baseline; or urine volume less than 0.5 mL/kg/h for 6 hours)
Time frame: First, second and fifth postoperative day
Intraoperative fluid dose
Intraoperative fluid administration
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Intraoperative vasopressor dose
Intraoperative vasopressor dose
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Rate of intra and postoperative atrial fibrillation
the occurrence of atrial fibrillation in the intraoperative and postoperative period up to 30 days
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
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