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Constructing a Risk Prediction Model for Intraoperative Hypothermia in Children Under General Anesthesia

Construction of a Risk Prediction Model for Hypothermia During Surgery in Pediatric Under General Anesthesia Based on Machine Learning Algorithm

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06892795
Enrollment
562
Registered
2025-03-25
Start date
2024-07-15
Completion date
2026-06-01
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Accidental, Hypothermia; Anesthesia

Brief summary

Intraoperative hypothermia refers to a core body temperature below 36.0°C during surgery, which is common in surgical patients. Due to the fact that children's body temperature regulation function is not yet fully developed, they are light in weight, and their blood vessels are superficial, children are very susceptible to the influence of environmental temperature. With the effects of anesthetic drugs, exposure of the surgical field, and disinfection of the surgical area, children face a higher risk of intraoperative hypothermia than adult patients. Studies have shown that the incidence of intraoperative hypothermia can be as high as 80%. Intraoperative hypothermia can lead to increased adverse cardiovascular events, poor coagulation, slower healing of surgical incisions, or wound infection, threatening the health of children, resulting in prolonged postoperative hospitalization and increased hospitalization costs. Therefore, there is an urgent need to develop a tool for predicting intraoperative hypothermia suitable for children, identify high-risk groups early, and take preventive measures as soon as possible, thereby reducing a series of complications caused by hypothermia. The purpose of this study is to clarify the current status and risk factors affecting intraoperative hypothermia in children, to provide a theoretical basis for clinical medical staff to provide intraoperative thermal insulation care for children, and on this basis to construct an intraoperative hypothermia risk prediction model to identify the probability of hypothermia in children at an early stage, so as to take targeted thermal insulation measures.

Detailed description

The study first clarified the overall incidence and influencing factors of IOH in children through meta-analysis, combined with expert consultation to determine potential predictive variables, and developed a data questionnaire for this study. The second part of the study will collect data prospectively, use four algorithms in machine learning, including logistic regression, decision tree, random forest, and support vector machine, to build an excellent intraoperative hypothermia risk prediction model, and conduct internal verification of the model. The third part of the study prospectively collects sample data to complete external verification of time period and space. The constructed model still has good predictive ability in the new data set. Finally, some models are visualized to form intuitive and easy-to-understand charts or interfaces.

Interventions

None listed

Sponsors

Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

Inclusion criteria

* Age \< 16 years old; * Anesthesia includes general anesthesia; * Anesthesia duration \> 30 minutes.

Exclusion criteria

* Cardiac surgery or other procedures that require lowering the child's body temperature; * Refusing to participate in this study; * ASA grade \>Ⅳ; * Abnormal basal body temperature, preoperative core body temperature \<36.0℃ or \>38.0℃; * Hyperthyroidism or hypothyroidism and other diseases that affect body temperature; * The core body temperature cannot be measured due to surgery or ear canal disease.

Design outcomes

Primary

MeasureTime frameDescription
Core body temperatureThe investigators will measure the child's core body temperature when the child enters the operating room, after induction of anesthesia, and then every 30 minutes until the end of the operation.Use an infrared electronic ear thermometer to measure the child's eardrum temperature as the core body temperature.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026