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Predicting Hypothermia in Gynecological Laparoscopic Surgery Using Machine Learning

NCT07353528 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-01-20

No results posted yet for this 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.

Conditions

  • Laparoscopic Surgery
  • Intraoperative Hypothermia
  • Gynecological Surgery

Sponsors & Collaborators

  • Sichuan Jinxin Xinan Women & Children's Hospital

    collaborator UNKNOWN

  • People ' s Hospital of Dayi County

    collaborator UNKNOWN

  • Medical Center Hospital of QiongLai City

    collaborator UNKNOWN

  • Chengdu Jinjiang Maternity and Child Health Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-03-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07353528 on ClinicalTrials.gov