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Starting soon Observational

Predicting Hypothermia in Gynecological Laparoscopic Surgery Using Machine Learning

NCT07353528 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-03-01
Last updated
2026-01-20

Condition(s) studied

Laparoscopic SurgeryIntraoperative HypothermiaGynecological Surgery

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female patients aged 18 years or older. * Patients scheduled for laparoscopic surgery. Exclusion Criteria: * Preoperative body temperature exceeding 37.5°C or below 36.0°C. * History of hypothyroidism or hyperthyroidism. * Patients with thermoregulatory dysfunction, such as severe infection or central nervous system disorders. * Patients who refuse to sign the informed consent form.

Primary outcome measure(s)

  • Area Under the Receiver Operating Characteristic Curve (AUC) of the machine learning model for predicting intraoperative hypothermia — During surgery
    The primary outcome is the discriminatory performance of the developed machine learning model for predicting the occurrence of intraoperative hypothermia (defined as a core temperature \< 36.0°C), as measured by the Area Under the Receiver Operating Characteristic Curve (AUC) evaluated on the independent testing set.

Trial sites (4)

FacilityCityRegionStatus
Chengdu Jinjiang District Women & Children Health Hospital Chengdu Sichuan
Sichuan Jinxin Xinan Women & Children's Hospital Chengdu Sichuan
People ' s Hospital of Dayi County Chengdu Sichuan
Medical Center Hospital of QiongLai City Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07353528 on ClinicalTrials.gov ↗ ← All trials in China