Validation of a non-invasive device to predict low blood pressure during surgery
External Validation of Prediction Algorithm Using Non-invasive Monitoring Device for Intraoperative Hypotension
This study is testing a new device that can help doctors predict low blood pressure during surgery to keep patients safer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06897514 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a prediction algorithm that uses non-invasive monitoring devices to effectively predict intraoperative hypotension during elective surgeries. The study focuses on utilizing commonly available monitoring tools such as blood pressure, ECG, and oxygen saturation to enhance patient safety by anticipating drops in blood pressure. By analyzing data from previous surgeries, the researchers hope to confirm the algorithm's accuracy and reliability in a clinical setting. The ultimate goal is to enable anesthesiologists to take preventive measures against hypotension, thereby reducing postoperative complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 19 or older undergoing elective surgery under general anesthesia with an ASA physical status of I to III.
Not a fit: Patients who may not benefit from this study include those requiring invasive arterial cannulation, emergency surgeries, or those who are pregnant or lactating.
Why it matters
Potential benefit: If successful, this study could significantly improve patient outcomes by allowing for timely interventions to prevent intraoperative hypotension.
How similar studies have performed: Previous studies have shown promise in using prediction algorithms for intraoperative hypotension, but this specific approach utilizing non-invasive devices is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults patients aged 19 or more * Elective surgery under general anesthesia * American Society of Anesthesiologists physical status I - III Exclusion Criteria: * Vasopressor/Inotrope usage before surgery * Patients who needs invasive arterial cannulation * Emergency surgery * Pregnant or lactating women
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyun Joo Ahn, MD PhD — Samsung Medical Center
- Study coordinator: Hyun Joo Ahn, MD PhD
- Email: hyunjooahn@skku.edu
- Phone: 821099330784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.