Status:
COMPLETED
"AI-Based Noninvasive Blood Pressure Monitoring Compared to Invasive Arterial Measurement"
Lead Sponsor:
Nevsehir Public Hospital
Conditions:
Blood Pressure Measurement
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this clinical trial is to evaluate a new, noninvasive method for continuously measuring blood pressure during surgery. This method combines two common types of signals - pulse oximetry and...
Detailed Description
Intraoperative blood pressure management plays a critical role in preventing postoperative complications, including organ dysfunction. While oscillometric intermittent noninvasive techniques are the s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06915376
Start Date
April 7 2025
End Date
November 20 2025
Last Update
November 21 2025
Active Locations (1)
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1
Konya City Hospital
Konya, Konya/Meram, Turkey (Türkiye), 42040