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

NCT06892795 | Enrolling By Invitation

• 2 other identifiers: LC2024-141YJSCX2024-124HYD
• Study Type: observational
• Target: 562
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Accidental; Hypothermia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Core body temperature

  Use an infrared electronic ear thermometer to measure the child's eardrum temperature as the 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.

Study Arms (2)

Hypothermia

Core body temperature below 36°C during surgery

Non-hypothermia

Core body temperature ≥ 36°C during surgery

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric surgical patients receiving general anesthesia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150023, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will not collect any biological specimens

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huanglu Lan

  The Sixth Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 25, 2025
• Study Start: July 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

CN (1)