Hypothermia, AccidentalNCT06892795
Constructing a Risk Prediction Model for Intraoperative Hypothermia in Children Under General Anesthesia
An observational study of Hypothermia, Accidental and Hypothermia; Anesthesia, run by Harbin Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Hypothermia, Accidental, Hypothermia; Anesthesia
- How many people
- 562 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 1 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric surgical patients receiving general anesthesia
Who may be able to join
- Age < 16 years old;
- Anesthesia includes general anesthesia;
- Anesthesia duration > 30 minutes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150023
About this study
Official title: Construction of a Risk Prediction Model for Hypothermia During Surgery in Pediatric Under General Anesthesia Based on Machine Learning Algorithm
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.
Read the 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.
- Conditions
- Hypothermia, Accidental, Hypothermia; Anesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Core body temperature below 36°C during surgery | |
| Non-hypothermia | Core body temperature ≥ 36°C during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Use an infrared electronic ear thermometer to measure the child's eardrum temperature as the core body temperature.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, AccidentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 562 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanglu Lan, Harbin Medical University
- Investigators
- Huanglu Lan, Principal investigator, The Sixth Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892795
- Sponsor's protocol ID
- LC2024-141
- Other IDs
- YJSCX2024-124HYD
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Risk Prediction Model for Hypothermia During Surgery in Pediatric Under General Anesthesia Based on Machine Learning Algorithm
- ClinicalTrials.gov ID
- NCT06892795
- Acronym / sponsor ID
- LC2024-141
- Conditions
- Hypothermia, Accidental, Hypothermia; Anesthesia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | – | –Core body temperature below 36°C during surgery |
| Non-hypothermia | – | –Core body temperature ≥ 36°C during surgery |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric surgical patients receiving general anesthesia
Key inclusion criteria (3 listed)
- Age < 16 years old;
- Anesthesia includes general anesthesia;
- Anesthesia duration > 30 minutes.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Core body temperature
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huanglu Lan principal investigator
The Sixth Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, Accidental and Hypothermia; Anesthesia, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.