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NCT07353528

Predicting Hypothermia in Gynecological Laparoscopic Surgery Using Machine Learning

Sponsor: Chengdu Jinjiang Maternity and Child Health Hospital

View on ClinicalTrials.gov

Summary

Brief Title: Predicting Hypothermia in Gynecological Laparoscopic Surgery Using Machine Learning Brief Summary: This study aims to develop and validate a machine learning model for predicting intraoperative hypothermia (IOH) in patients undergoing gynecological laparoscopic surgery based on preoperative clinical indicators. This prospective, multicenter case-control study will enroll female patients aged 18 years and older who are scheduled for laparoscopic surgery across multiple hospitals from 2026 to 2027. The primary objective is to identify high-risk patients who may experience IOH, defined as a core temperature below 36.0°C during surgery. Participants will be classified into two groups: the IOH group, consisting of patients who experience hypothermia, and the normal temperature group, comprising patients who maintain a core temperature of 36.0°C or higher. Data collection will include demographics, comorbidities, surgical details, anesthesia information, and preoperative laboratory results. The primary outcome measure will be the area under the curve (AUC) of the model, assessing its predictive performance at various thresholds. Secondary outcomes will include sensitivity, positive predictive value, negative predictive value, and F1 score. The study hypothesizes that the developed machine learning model will significantly improve the accuracy and timeliness of predicting IOH, thereby enhancing patient safety during surgery and postoperative recovery. This research is expected to inform clinical practices related to preventative warming strategies, ultimately improving patient outcomes in gynecological laparoscopic surgery.

Official title: Development and Validation of a Machine Learning Model to Predict Hypothermia in Gynecological Laparoscopic Surgery Based on Preoperative Clinical Indicators: A Multicenter Prospective Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-03-01

Completion Date

2026-07-01

Last Updated

2026-01-20

Healthy Volunteers

No

Locations (4)

Chengdu Jinjiang District Women & Children Health Hospital

Chengdu, Sichuan, China

Sichuan Jinxin Xinan Women & Children's Hospital

Chengdu, Sichuan, China

People ' s Hospital of Dayi County

Chengdu, Sichuan, China

Medical Center Hospital of QiongLai City

Chengdu, Sichuan, China