Comparing two methods to prevent low blood pressure during surgery
Randomized Controlled Trial Comparing HPI and Elevated Threshold Monitor Alarms in Preventing Intraoperative Hypotension
This study is testing if a new method for predicting low blood pressure during surgery can work better than the usual alarm system to keep patients safe while under anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 2 sites (Hsin Chu and 1 other locations) |
| Trial ID | NCT06631482 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Hypotension Prediction Index (HPI) compared to a traditional alarm threshold of 73 mmHg in preventing intraoperative hypotension (IOH) during surgeries requiring general anesthesia. Patients will be randomly assigned to either the HPI group, where interventions are initiated based on HPI values exceeding 85, or the control group with the alarm set at 73 mmHg. The study aims to determine if the predictive capabilities of HPI provide a significant advantage over the standard alarm threshold in managing blood pressure during surgery. The findings could influence future practices in anesthesiology and patient care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing surgeries requiring general anesthesia lasting more than two hours with a high cardiovascular risk.
Not a fit: Patients with mild systemic disease, pregnant women, or those with severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of blood pressure during surgery, reducing the risk of postoperative complications.
How similar studies have performed: Previous observational studies have shown promising results for the HPI, suggesting its predictive accuracy is comparable to raising the alarm threshold, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A: Patients undergoing surgeries requiring general anesthesia lasting more than two hours, and requiring continuous arterial blood pressure monitoring via arterial catheter according to standard medical practice. This includes: ASA Class II or higher. Estimated surgery duration of three hours or more. High cardiovascular risk, such as poorly controlled hypertension, diabetes, coronary artery disease, chronic kidney disease, or chronic emphysema. * B: Patients aged 18 years or older. Exclusion Criteria: * ASA Class I: Patients with mild systemic disease. * Pregnancy: Pregnant women. * End-stage renal disease: Patients with eGFR below 30 ml/min/1.73 m². * Cardiac shunt: Presence of intracardiac shunt. * Severe arrhythmias: Including supraventricular tachycardia (heart rate \>100 bpm), ventricular tachycardia, or ventricular fibrillation. * Factors affecting SVV accuracy: Conditions such as atrial fibrillation (A-Fib) or thoracic surgery that can invalidate stroke volume variation (SVV) measurements.
Where this trial is running
Hsin Chu and 1 other locations
- National Taiwan University Hospital Hsin-Chu Branch — Hsin Chu, Taiwan (Recruiting)
- National Taiwan University Hosipital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Tsung Ta Wu, MD. — National Taiwan University Hospital Hsinchu branch
- Study coordinator: Tsung Ta Wu, MD
- Email: tsungta.wu@gmail.com
- Phone: +88635326151
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.