Predicting Hypothermia in Gynecological Laparoscopic Surgery Using Machine Learning

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Conditions studied: Laparoscopic Surgery, Intraoperative Hypothermia, Gynecological Surgery

In brief

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.

Key facts

Study ID: NCT07353528
Run by: Chengdu Jinjiang Maternity and Child Health Hospital
People needed: 1000
Starts: 2026-03-01
Expected to finish: 2026-07-01
Last updated by the study team: 2026-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female patients aged 18 years or older.
Patients scheduled for laparoscopic surgery.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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