Randomized Controlled Trial Comparing HPI and Elevated Threshold Monitor Alarms in Preventing Intraoperative Hypotension

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hosipital
RECRUITING
Taipei
National Taiwan University Hospital Hsin-Chu Branch
RECRUITING
Taoyuan District
Contact Information
Primary
Tsung Ta Wu, MD
tsungta.wu@gmail.com
+88635326151
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 100
Treatments
Experimental: HPI Group
Use the hypotension predictive index (HPI)-guided protocol to prevent intraoperative hypotension, initiating treatmentusing the fluid administration or intravenous norepinephrine infusion to keep intraoperative HPI below 85.
Active_comparator: 73mmHg MAP Alarm Group
Intraoperative maintenance of the mean arterial pressure (MAP) at 73 mmHg or higher by using the fluid administration or intravenous norepinephrine infusion.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov