NCT07396636 Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
| NCT ID | NCT07396636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nevsehir Public Hospital |
| Condition | Intraoperative Hypotension |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-03-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intraoperative hypotension, defined as a drop in blood pressure during surgery, is a frequent event in patients undergoing general anesthesia. Even brief episodes of low blood pressure may reduce blood flow to vital organs such as the brain, heart, and kidneys, and have been associated with an increased risk of postoperative complications, prolonged recovery, and worse clinical outcomes. Despite its clinical importance, the management of intraoperative hypotension is often based on general guidelines and individual clinician experience rather than patient-specific physiological mechanisms. Low blood pressure during surgery can occur for different underlying reasons, including reduced circulating blood volume, excessive vasodilation caused by anesthetic agents, impaired heart contractility, or abnormalities in heart rate. In routine practice, these mechanisms are not always clearly distinguished, and similar treatment strategies may be applied to patients with different physiological causes of hypotension. As a result, the response to treatment can vary widely between patients. This prospective observational study aims to improve the understanding of intraoperative hypotension by collecting detailed hemodynamic data during surgery and analyzing these data using machine learning methods. The study is designed to observe current clinical practice without altering or interfering with routine patient care. All decisions regarding anesthesia management and treatment of hypotension will be made by the attending anesthesiologists according to standard clinical practice. The research team will not provide treatment recommendations during surgery. Adult patients undergoing elective surgery under general anesthesia with continuous invasive arterial blood pressure monitoring will be included. During the intraoperative period, blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance, and other advanced hemodynamic parameters will be continuously recorded at regular intervals. When hypotension occurs, the onset, duration, and severity of the episode will be documented, along with the treatment applied, such as fluid administration, vasopressor agents, or inotropic medications. The time required for blood pressure to recover to an acceptable level will also be recorded. The collected data will be analyzed using machine learning techniques to identify distinct subtypes of intraoperative hypotension based on physiological patterns. These subtypes may reflect different underlying mechanisms, such as hypovolemia, vasodilation, myocardial depression, or heart rate-related causes. In addition, the study will evaluate how different treatment strategies perform across these hypotension subtypes and how quickly hemodynamic stability is restored. Patient-related factors such as age, sex, body mass index, physical status classification, and comorbid conditions will also be examined to determine their relationship with the occurrence, severity, and treatment response of hypotension episodes. By combining patient characteristics, physiological data, and treatment responses, the study aims to generate data-driven insights into personalized hypotension management. The ultimate goal of this research is to support the development of individualized treatment recommendations for intraoperative hypotension based on objective physiological data rather than a one-size-fits-all approach. The findings of this study are expected to provide a strong scientific foundation for future clinical decision-support systems that can assist anesthesiologists in selecting the most appropriate treatment strategy for each patient. By improving the precision of blood pressure management during surgery, this approach has the potential to enhance patient safety and perioperative outcomes while maintaining standard clinical workflows.
Eligibility Criteria
Inclusion Criteria: * Adult patients aged 18 years or older * Patients scheduled for elective surgical procedures * Procedures performed under general anesthesia * Availability of continuous invasive arterial blood pressure monitoring during the intraoperative period * Planned surgical duration of at least 2 hours * Ability to provide written informed consent for participation in the study Exclusion Criteria: * Emergency surgery * Diagnosis of sepsis, septic shock, or advanced cardiogenic shock * Cardiac rhythm disturbances that prevent reliable hemodynamic measurements (e.g., atrial fibrillation) * Severe left ventricular dysfunction or advanced heart failure (ejection fraction \<30%) * Inability to maintain intraoperative arterial cannulation due to technical or clinical reasons * Inability to provide informed consent (e.g., cognitive impairment or refusal to participate)
Contact & Investigator
Mehmet Akif Yazar, MD, PhD, Assoc. Prof
STUDY DIRECTOR
Konya City Hospital
Frequently Asked Questions
Who can join the NCT07396636 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intraoperative Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07396636 currently recruiting?
Yes, NCT07396636 is actively recruiting participants. Contact the research team at makifyazar@hotmail.com for enrollment information.
Where is the NCT07396636 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT07396636 clinical trial?
NCT07396636 is sponsored by Nevsehir Public Hospital. The principal investigator is Mehmet Akif Yazar, MD, PhD, Assoc. Prof at Konya City Hospital. The trial plans to enroll 50 participants.