Prediction of intraoperative hypotension using deep learning models based on non-invasive monitoring devices.
Heejoon Jeong, Donghee Kim, Dong Won Kim...
https://pubmed.ncbi.nlm.nih.gov/39158783Actively Recruiting
Age: 19Years +
All Genders
ID06897514
External Validation of Prediction Algorithm Using Non-invasive Monitoring Device for Intraoperative Hypotension
Led by Samsung Medical Center · Updated on 2025-05-15
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a prediction algorithm that uses non-invasive monitoring devices to forecast low blood pressure during surgery, a condition called intraoperative hypotension. This condition is linked to poorer outcomes after surgery, including complications like kidney injury. The study aims to test how well this algorithm works in real clinical settings and to assess its usefulness and limitations. Participants will undergo general anesthesia for elective surgery while connected to five common non-invasive monitoring devices: blood pressure, electrocardiogram, oxygen saturation, carbon dioxide levels, and anesthesia depth monitors. Data from these devices will be analyzed by the prediction algorithm to anticipate hypotension events. This study follows a single group design without comparison arms. During the study, participants will be closely monitored throughout their surgery with these devices. Researchers will measure the algorithm's accuracy by analyzing how well it predicts hypotension five minutes before it occurs. This involves collecting and assessing data during anesthesia to confirm the algorithm's performance. The total study period includes preoperative preparation and surgery monitoring, with data analysis concluding after the surgery.
CONDITIONS
Brief Title
External Validation of Prediction Algorithm Using Non-invasive Monitoring Device for Intraoperative Hypotension
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults patients aged 19 or more
- Elective surgery under general anesthesia
- American Society of Anesthesiologists physical status I - III
You will not qualify if you...
- Vasopressor/Inotrope usage before surgery
- Patients who needs invasive arterial cannulation
- Emergency surgery
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Diagnostic Evaluation
Duration - Duration of surgery
Participants undergo non-invasive monitoring during their elective surgery while the prediction algorithm for intraoperative hypotension is applied.
1 surgical visit (in-person)
Long-term Monitoring
Duration - Up to 5 minutes before occurrence of hypotension during surgery
Participants are observed postoperatively to evaluate the predictive accuracy of the hypotension algorithm during general anesthesia.
Postoperative monitoring as part of routine care
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
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Research Team
H
Hyun Joo Ahn, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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