Comparison Bewteen Intraoperative HPI vs. High Mean Arterial Pressure Threshold (NCT06631482) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison Bewteen Intraoperative HPI vs. High Mean Arterial Pressure Threshold
Taiwan100 participantsStarted 2024-09-16
Plain-language summary
Intraoperative hypotension (IOH) is a common and serious complication during surgery, closely associated with poor postoperative outcomes. Traditionally, anesthesiologists rely on real-time physiological parameters and alarms to monitor blood pressure, but the low alarm thresholds may lead to delayed interventions. The Hypotension Prediction Index (HPI) is a novel predictive tool that uses arterial waveform signals and advanced algorithms to forecast hypotensive events in advance. Recent observational studies have shown that HPI's accuracy in predicting hypotension is highly consistent with setting the physiological monitor's alarm threshold to 73 mmHg. This study will compare the effectiveness of HPI and a raised alarm threshold of 73 mmHg in preventing IOH. While HPI is promising with its AI-assisted approach to patient care, its high cost due to the advanced technology raises concerns. If its accuracy is comparable to simply raising the traditional monitor threshold, it may not lead to substantial changes in clinical practice.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Time-Weighted Average (TWA) for MAP below 65 mmHg During Surgery
Timeframe: From the start of surgery to the end of surgery, approximately up to 12 hours, depending on the duration of the operation.
2
Comparison of Time-Weighted Average (TWA) for MAP above 100 mmHg During Surgery
Timeframe: From the start of surgery to the end of surgery, approximately up to 12 hours, depending on the duration of the operation.