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Enrolling by invitation Observational

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

NCT06892795 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-07-15
Last updated
2025-03-26

Condition(s) studied

Hypothermia, AccidentalHypothermia; Anesthesia

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
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.

Primary outcome measure(s)

  • Core body temperature — The 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.

Trial sites (1)

FacilityCityRegionStatus
The Sixth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
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 NCT06892795 on ClinicalTrials.gov ↗ ← All trials in China