AI Prediction of Post-Induction Hypotension in Cesarean Sections With Spinal Anesthesia

NCT06158542 | Completed

• 1 other identifier: GO 22/1285
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

The cesarean section, medically necessary for both the mother and the baby in certain cases, is a life-saving operation.The most commonly used anesthesia method worldwide is spinal anesthesia. While spinal anesthesia has many advantages, it also has disadvantages. One of the most commonly encountered disadvantages is the development of hypotension due to the unopposed parasympathetic response after induction. Determining which patient will develop hypotension and which patient will not remains an important question for anesthesiologists before surgery. Identifying high-risk patients for hypotension before starting spinal anesthesia and even knowing the percentage of patients who will develop hypotension undoubtedly saves time in problem-solving. From this perspective, the idea for this study emerged: identifying parameters with the potential for use in prediction based on the literature, collecting data, then testing the relationship between them using machine learning methods, and developing an algorithm capable of predictive analysis. At the end of the study, an artificial intelligence algorithm for predicting hypotension after induction will be developed, and its performance will be tested. The main goals of the study: i)Create a dataset including the clinical characteristics, demographic data, and blood test results of patients who develop and do not develop hypotension after spinal anesthesia. ii) Develop an artificial intelligence algorithm using the dataset and determine the most accurate algorithm for predicting hypotension. iii) To test the accuracy of the developed algorithm, create a test dataset, measure and optimize the algorithm's performance. Accuracy, sensitivity, specificity, and Receiver Operating Characteristic (ROC) curves will be used for performance measurement. iv) Create a suitable interface (a surface for interaction with the software) to make the developed algorithm usable in clinical practice.

Conditions

Spinal Anesthesia Induced Hypotension; Caeserian Section

Keywords

spinal anesthesia; artificial intelligence; hypotension; anesthesia

Outcome Measures

Primary Outcomes (1)

• The Low Blood Pressure Measured by Non-Invasive Methods

  Mean arterial pressure falling below 65 mmHg • Systolic blood pressure dropping below 80 mmHg • Systolic blood pressure falling below 75% of baseline • Onset of hypotension symptoms such as dizziness, increased salivation, shortness of breath, nausea, and vomiting.

  The first 15 minutes after the administration of spinal anesthesia

Study Arms (1)

The women meeting the inclusion criteria, undergoing cesarean section

Women who meet the inclusion criteria and have undergone spinal anesthesia for cesarean section between December 2023 and April2024

Procedure: Spinal Anesthesia; Diagnostic Test: Blood Sampling

Interventions

Spinal Anesthesia PROCEDURE

After standard monitoring, the patient is placed in a sitting position for site marking and administration of anesthesia. The line connecting the upper border of the right and left iliac crests through conventional palpation of anatomical landmarks (Tuffier line) is identified as the entry point at the L3-L4 interspinous space or L2-L3 interspace. For patients in whom spinal entry is successful, spinal anesthesia is provided with the appropriate dose and types of local anesthetics (intrathecal 10-12 mg bupivacaine with the addition of 15-25 mcg fentanyl). After completing the procedure and placing the patient in the supine position, the block level is determined 10 minutes post-procedure using the ice test/pinprick test. Blocks reaching the T4-T6 level are considered successful.

The women meeting the inclusion criteria, undergoing cesarean section

Blood Sampling DIAGNOSTIC_TEST

Preoperatively, syndecan-1 serum levels will be investigated from the blood sample taken before cesarean section.

The women meeting the inclusion criteria, undergoing cesarean section

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will be conducted only on women since it will take place in patients undergoing cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The pregnant women at the delivery ward of Hacettepe University Hospital who have undergone a decision for cesarean section

You may qualify if:

• Being 18 years or older
• Having an American Society of Anesthesiologists (ASA) physical status of I, II, or III
• Gestational age of 37 weeks or more
• Having undergone spinal or combined spinal-epidural anesthesia

You may not qualify if:

• Patient's unwillingness to participate in the study
• Multiple pregnancies
• Emergency cesarean section
• Preeclampsia
• Preoperatively measured systolic blood pressure equal to or greater than 140mmHg (hypertensive pregnant woman)
• Having a contraindication to spinal anesthesia or experiencing spinal anesthesia failure

Sponsors & Collaborators

• Hacettepe University: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Hacettepe University Hospitals

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (22)

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  BACKGROUND

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MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, Spinal; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Banu Kilicaslan, Professor, MD

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: February 28, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TU (1)