HypothermiaNCT06836245
Multicenter Application of the Intraoperative Hypothermia Risk Prediction Scale and the Distribution of Risk Factor Characteristics in Surgical Patients
An observational study of Hypothermia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Research Plan 1.Data Collection and Quality Control Before the study begins, operating room nursing managers and clinical specialist nurses from 12 participating medical institutions will undergo unified online and offline training on intraoperative hypothermia assessment tools. The training will cover: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Measure the patient's body temperature intraoperatively using instruments
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 30 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical patients from all departments.
Who may be able to join
- Surgical patients aged ≥18 years;
- The patient or their family members are informed and consent. (Note: The informed consent form requirement for the patient and their family members has been removed from the inclusion criteria. This is because intraoperative hypothermia protection is currently a key aspect of patient surgical care and a major national quality improvement project in medical care. Intraoperative core temperature monitoring and temperature protection measures are required to be routinely performed, and the entire process involves no invasive procedures, so there is no need for a special consent form.)
Who cannot join
- Patients undergoing local anesthesia surgery;
- Surgical patients requiring controlled hypothermic treatment or special intraoperative temperature management;
- Surgical patients whose underlying disease affects the body's temperature regulation;
- Patients whose surgical data is incomplete and cannot be collected. (Note: 1. Anesthesia methods are divided into five categories, including local infiltration anesthesia, nerve block anesthesia, epidural anesthesia, non-intubated intravenous general anesthesia, and intubated general anesthesia. Here, surgical patients undergoing local infiltration anesthesia are excluded. 2. Special intraoperative temperature management refers to additional or bundled hypothermia protection measures added to the routine hypothermic care in the operating room.)
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei
Wuhan, Hubei, 430000
About this study
Research Plan
1.Data Collection and Quality Control
Read more
Before the study begins, operating room nursing managers and clinical specialist nurses from 12 participating medical institutions will undergo unified online and offline training on intraoperative hypothermia assessment tools. The training will cover:
- Risk factor assessment
- Use of the adult intraoperative hypothermia risk assessment scale
- Core body temperature measurement
- Prevention strategies for high-risk patients
- Management procedures following the occurrence of intraoperative hypothermia After the training, operating room nurses will be assessed on risk factor evaluation and the use of the adult intraoperative hypothermia risk assessment scale to ensure consistency across the 12 institutions. The research team will establish a multi-center database for critically ill surgical patients' intraoperative hypothermia and create a WeChat group for timely communication and problem-solving. Data collection will commence from September to November 2024, lasting three months. Core body temperature measurements will be taken at the following times: upon entering the operating room, baseline core temperature; during surgery, every 30 minutes from skin incision to departure from the operating room. After data collection, all original paper documents will be stored by the researchers, and data will be entered and saved electronically. Both computer data and original documents will be sealed after the study concludes, with all data used solely for this research.
2.Survey Tools
The research data collection tools include:
- Intraoperative Hypothermia Influencing Factors Collection Form: Collects general information about surgical patients, hypothermia nursing measures, and related influencing factors.
- Core Body Temperature Record Form: Records the patient's core body temperature from entering to leaving the operating room, with measurements taken every 30 minutes.
- Adult Intraoperative Hypothermia Risk Assessment Scale: Assessed before surgery by researchers or trained circulating nurses. The study will provide unified definitions and annotations for related hypothermia risk factors to facilitate training and ensure consistency among operating room nurses across the 12 institutions.
3.Data Preservation During the patient's surgery, researchers will use only the pre-designed paper data forms or electronic spreadsheets for data collection, avoiding the use of other electronic devices for activities like photography. The collected patient data will be used exclusively for this study. Patient-related surgical information will not be disclosed to any individuals unrelated to the research, except for sharing with research team members. During statistical analysis, personal privacy information will be removed to minimize the risk of data leakage.
- Conditions
- Hypothermia
- Being tested
- Measure the patient's body temperature intraoperatively using instruments
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure the patient's body temperature intraoperatively using instrumentsOther
- Core Body Temperature Measurement: Nasopharyngeal Temperature Probe: Insert the probe into the patient's nasal cavity to measure the temperature of the nasopharynx. Esophageal Probe: Insert the probe through the esophagus to measure the temperature of the lower esophagus. Bladder Temperature Probe: Insert the probe into the bladder to measure the temperature of the urine. Tympanic Temperature Probe: Place the probe in the ear canal to measure the temperature near the tympanic membrane.
- Peripheral Body Temperature Measurement:
Axillary: Place the thermometer under the armpit, suitable for routine temperature monitoring, but may not be as accurate as core temperature measurement.
Oral: Place the thermometer under the tongue, suitable for conscious and cooperative patients.
Rectal: Insert the thermometer into the rectum to provide an accurate temperature measurement, but may not be suitable for all patients, especially those with rectal diseases or immunosuppressed conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical patient body temperature.
Measured: 2024.9.15-2025.2.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Sep 2024
- Primary completion30 Mar 2025
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836245
- Sponsor's protocol ID
- 016-03-01
- Status last verified
- Sep 2024
- First submitted
- 14 Feb 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Privacy and Confidentiality: Protecting the privacy of patients is crucial. IPD often contains sensitive personal health information, and unauthorized sharing may violate privacy protection regulations. 2. Informed Consent: Patients typically need to sign an informed consent form when participating in a study, clearly stating the scope of data usage and sharing. If the consent form does not explicitly authorize sharing of IPD, the data cannot be made public or shared. 3. Data Security: IPD requires strict security measures to prevent unauthorized access and misuse. Data sharing can only be considered once data security is ensured. 4. Ethical Guidelines: According to the ethical requirements and approval of the ethics committee, data sharing may be restricted, especially when dealing with vulnerable groups or sensitive diseases.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Application of the Intraoperative Hypothermia Risk Prediction Scale and the Distribution of Risk Factor Characteristics in Surgical Patients
- ClinicalTrials.gov ID
- NCT06836245
- Acronym / sponsor ID
- 016-03-01
- Conditions
- Hypothermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 20 Feb 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.
Research Plan
1.Data Collection and Quality Control
Before the study begins, operating room nursing managers and clinical specialist nurses from 12 participating medical institutions will undergo unified online and offline training on intraoperative hypothermia assessment tools. The training will cover:
- Risk factor assessment
- Use of the adult intraoperative hypothermia risk assessment scale
- Core body temperature measurement
- Prevention strategies for high-risk patients
- Management procedures following the occurrence of intraoperative hypothermia After the training, operating room nurses will be assessed on risk factor evaluation and the use of the adult intraoperative hypothermia risk assessment scale to ensure consistency across the 12 institutions. The research team will establish a multi-center database for critically ill surgical patients' intraoperative hypothermia and create a WeChat group for timely communication and problem-solving. Data collection will commence from September to November 2024, lasting three months. Core body temperature measurements will be taken at the following times: upon entering the operating room, baseline core temperature; during surgery, every 30 minutes from skin incision to departure from the operating room. After data collection, all original paper documents will be stored by the researchers, and data will be entered and saved electronically. Both computer data and original documents will be sealed after the study concludes, with all data used solely for this research.
2.Survey Tools
The research data collection tools include:
- Intraoperative Hypothermia Influencing Factors Collection Form: Collects general information about surgical patients, hypothermia nursing measures, and related influencing factors.
- Core Body Temperature Record Form: Records the patient's core body temperature from entering to leaving the operating room, with measurements taken every 30 minutes.
- Adult Intraoperative Hypothermia Risk Assessment Scale: Assessed before surgery by researchers or trained circulating nurses. The study will provide unified definitions and annotations for related hypothermia risk factors to facilitate training and ensure consistency among operating room nurses across the 12 institutions.
3.Data Preservation During the patient's surgery, researchers will use only the pre-designed paper data forms or electronic spreadsheets for data collection, avoiding the use of other electronic devices for activities like photography. The collected patient data will be used exclusively for this study. Patient-related surgical information will not be disclosed to any individuals unrelated to the research, except for sharing with research team members. During statistical analysis, personal privacy information will be removed to minimize the risk of data leakage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients from all departments.
Key inclusion criteria (2 listed)
- Surgical patients aged ≥18 years;
- The patient or their family members are informed and consent. (Note: The informed consent form requirement for the patient and their family members has been removed from the inclusion criteria. This is because intraoperative hypothermia protection is currently a key aspect of patient surgical care and a major national quality improvement project in medical care. Intraoperative core temperature monitoring and temperature protection measures are required to be routinely performed, and the entire process involves no invasive procedures, so there is no need for a special consent form.)
Key exclusion criteria (4 listed)
- Patients undergoing local anesthesia surgery;
- Surgical patients requiring controlled hypothermic treatment or special intraoperative temperature management;
- Surgical patients whose underlying disease affects the body's temperature regulation;
- Patients whose surgical data is incomplete and cannot be collected. (Note: 1. Anesthesia methods are divided into five categories, including local infiltration anesthesia, nerve block anesthesia, epidural anesthesia, non-intubated intravenous general anesthesia, and intubated general anesthesia. Here, surgical patients undergoing local infiltration anesthesia are excluded. 2. Special intraoperative temperature management refers to additional or bundled hypothermia protection measures added to the routine hypothermic care in the operating room.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure the patient's body temperature intraoperatively using instruments1. Core Body Temperature Measurement: Nasopharyngeal Temperature Probe: Insert the probe into the patient's nasal cavity to measure the temperature of the nasopharynx. Esophageal Probe: Insert the probe through the esophagus to measure the temperature of the lower esophagus. Bladder Temperature Probe: Insert the probe into the bladder to measure the temperature of the urine. Tympanic Temperature Probe: Place the probe in the ear canal to measure the temperature near the tympanic membrane. 2. Peripheral Body Temperature Measurement: Axillary: Place the thermometer under the armpit, suitable for routine temperature monitoring, but may not be as accurate as core temperature measurement. Oral: Place the thermometer under the tongue, suitable for conscious and cooperative patients. Rectal: Insert the thermometer into the rectum to provide an accurate temperature measurement, but may not be suitable for all patients, especially those with rectal diseases or immunosuppressed conditions. | Other | – |
Primary outcome
Surgical patient body temperature.
Time frame: 2024.9.15-2025.2.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No. 1. Privacy and Confidentiality: Protecting the privacy of patients is crucial. IPD often contains sensitive personal health information, and unauthorized sharing may violate privacy protection regulations. 2. Informed Consent: Patients typically need to sign an informed consent form when participating in a study, clearly stating the scope of data usage and sharing. If the consent form does not explicitly authorize sharing of IPD, the data cannot be made public or shared. 3. Data Security: IPD requires strict security measures to prevent unauthorized access and misuse. Data sharing can only be considered once data security is ensured. 4. Ethical Guidelines: According to the ethical requirements and approval of the ethics committee, data sharing may be restricted, especially when dealing with vulnerable groups or sensitive diseases.
Related trials for Hypothermia
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 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?
Results are not available in the source record.
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?
Surgical patient body temperature. (time frame: 2024.9.15-2025.2.30). 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 23 Jul 2025.