Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range.
Xiang Wan, Wenqian Wang, Jiming Liu...
https://pubmed.ncbi.nlm.nih.gov/25524443Actively Recruiting
Led by National and Kapodistrian University of Athens · Updated on 2026-04-20
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
N
National and Kapodistrian University of Athens
Lead Sponsor
A
Attikon Hospital
Collaborating Sponsor
Researchers are evaluating if combining the Hypotension Prediction Index (HPI) with Assisted Fluid Management (AFM) software can improve the management of blood pressure during general anesthesia in adults. The study aims to find out whether using HPI and AFM reduces the occurrence and length of low blood pressure during surgery, optimizes fluid and medication use, and improves overall outcomes. This is a prospective, randomized trial involving adult patients undergoing elective surgery requiring invasive blood pressure monitoring. Participants will be randomly assigned to one of two groups. The experimental group will receive goal-directed hemodynamic therapy guided by HPI and AFM software using the Hemosphere monitor and Acumen IQ sensor. This system helps predict low blood pressure before it happens and guides fluid administration based on heart function. The control group will receive standard care based on the anesthesiologist's clinical judgment; although the Acumen IQ sensor will be used, its outputs will not be visible or used in decision-making. Both groups will be monitored continuously during surgery. Participants will have invasive blood pressure monitoring throughout surgery, with data recorded by the research team. The main measure is the time-weighted average of hypotension, defined as mean arterial pressure below 65 mm Hg for at least one minute during surgery. Secondary measures include how often and how long hypotension occurs, the types and amounts of fluids and medications given, and adherence to the treatment protocol. The study is expected to conclude in March 2027.
CONDITIONS
Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery duration expected to be more than 2 hours
Participants undergo surgery under general anesthesia. Those in the experimental group receive goal-directed hemodynamic therapy guided by the Hypotension Prediction Index and Assisted Fluid Management software to prevent or treat intraoperative hypotension. Participants in the control group receive conventional hemodynamic management based on clinical judgement. Hemodynamic data are continuously recorded during surgery.
1 intraoperative visit (in-person)
Total: 1 location
1
2nd University Department of Anesthesiology, Attikon University Hospital
Athens, Attica, Greece, 12462
Actively Recruiting
G
Georgia Ntalamagka, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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