Development of an Artificial Intelligence Algorithm to Predict Hypotension Risk After Induction in Cesarean Sections With Spinal Anesthesia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
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.

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

• 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

Locations
Other Locations
Turkey
Hacettepe University Hospitals
RECRUITING
Ankara
Contact Information
Primary
Samet Yavuzel, MD
yavuzelsamet@gmail.com
+90 312 305 12 50
Backup
Banu Kılıçaslan, Professor, MD
banuk9oct@gmail.com
Time Frame
Start Date: 2023-12-24
Estimated Completion Date: 2024-05-24
Participants
Target number of participants: 370
Treatments
The women meeting the inclusion criteria, undergoing cesarean section
Women who meet the inclusion criteria and have undergone spinal anesthesia for cesarean section between November 2023 and March 2024
Related Therapeutic Areas
Sponsors
Collaborators: Cedars-Sinai Medical Center, Hacettepe University Scientific Research Projects Coordination Unit
Leads: Hacettepe University

This content was sourced from clinicaltrials.gov