Noninvasive blood pressure monitoring using AI during surgery

Comparison of Noninvasive Continuous Blood Pressure Measurement Using Artificial Intelligence-Assisted Pulse Oximetry and Electrocardiography Signal Combination With Invasive Arterial Blood Pressure

This study tests a new way to monitor blood pressure without needles during surgery to see if it works safely for high-risk patients who need close monitoring.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nevsehir Public Hospital (Government)
• Locations: 1 site (Konya, Konya/Meram)
• Trial ID: NCT06915376 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a new noninvasive method for continuously measuring blood pressure during surgery by combining pulse oximetry and electrocardiography signals with artificial intelligence. The goal is to determine if this method can safely replace the standard invasive arterial blood pressure monitoring in certain surgical situations. The study focuses on high-risk patients who require continuous blood pressure monitoring to prevent complications during critical surgical moments. Researchers will compare the accuracy and safety of this noninvasive approach against traditional invasive methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older undergoing non-cardiac surgery with a planned duration of over 60 minutes.

Not a fit: Patients with severe peripheral vascular disease or those undergoing surgeries involving major arteries may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could reduce complications associated with invasive blood pressure monitoring while providing accurate continuous measurements.

How similar studies have performed: While noninvasive blood pressure monitoring has been explored, this specific hybrid approach using AI is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Clinical indication for arterial catheter placement
* Age ≥18 years
* American Society of Anesthesiologists (ASA) physical status classification ≤3
* Planned surgical duration \>60 minutes
* Non-cardiac surgery
* Expected supine positioning during the procedure
* Initial postoperative recovery planned in the Post-Anesthesia Care Unit (PACU)

Exclusion Criteria:

* Refusal to give informed consent
* Severe peripheral vascular disease
* Surgeries involving manipulation of major arteries
* Positive Allen's test
* Inability to place an arterial catheter in the upper extremity
* Presence of an arteriovenous fistula for hemodialysis
* Inability to measure NIBP (noninvasive blood pressure) on the same arm as the arterial catheter
* Difference greater than 10 mmHg in SBP or DBP between the two arms based on NIBP measurements
* Abnormal arterial pressure waveforms detected in history or initial IABP monitoring (e.g., pulsus paradoxus, pulsus alternans, pulsus bisferiens, pulsus parvus et tardus)
* Atrial fibrillation
* Body Mass Index (BMI) \>35 kg/m²
* Preoperative hemoglobin level \<10 g/dL or \>16 g/dL
* Esophageal or nasopharyngeal pathology, or aortic coarctation
* Conditions affecting accurate pulse oximeter readings, such as nail or finger disorders (e.g., nail fungus or scleroderma), or presence of nail polish, dye, henna, or tattoos on fingers or nails.

Where this trial is running

Konya, Konya/Meram

• Konya City Hospital — Konya, Konya/Meram, Turkey (Recruiting)

Study contacts

• Principal investigator: Mehmet Akif Yazar, MD — Konya City Hospital
• Study coordinator: Mehmet Akif Yazar, MD

Conditions Blood Pressure Measurement; Noninvasive Blood Pressure Monitoring; Photoplethysmography; Artificial Intelligence; Intraoperative Hemodynamics