An observational study in Hypothermia, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational
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:
2.Survey Tools
The research data collection tools include:
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 95 across 106 observational studies indexed under Hypothermia.
Browse Hypothermia studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Surgical patients from all departments.
Inclusion Criteria:
Inclusion criteria for patients:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. 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.
Surgical patient body temperature.
Time frame: 2024.9.15-2025.2.30
Plan to share: No — 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. 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. Data Security: IPD requires strict security measures to prevent unauthorized access and misuse. Data sharing can only be considered once data security is ensured. 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.
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Mar 2025, 6 months.
Of 47 non-industry observational studies under Hypothermia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 50. This study's 6 months is below that.
Counting every sponsor, half of 48 studies reached it within 12 months; a quarter within 4 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →