NCT06836245

Multicenter Application of the Intraoperative Hypothermia Risk Prediction Scale and the Distribution of Risk Factor Characteristics in Surgical Patients

ENROLLING BY INVITATION Last updated 23 July 2025

What this trial tests

trial testing Measure the patient's body temperature intraoperatively using instruments in Hypothermia in 5,000 participants. Enrolling by invitation.

Timeline

15 September 2024

Primary endpoint
30 March 2025

30 July 2025

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	15 September 2024
Primary completion	30 March 2025
Estimated completion	30 July 2025
Sites	1 location across China

Drugs / interventions tested

• Measure the patient's body temperature intraoperatively using instruments

Conditions studied

• Hypothermia — all drugs for Hypothermia →

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

18 and older, any sex, with Hypothermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Risk factor assessment
2. Use of the adult intraoperative hypothermia risk assessment scale
3. Core body temperature measurement
4. Prevention strategies for high-risk patients
5. 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:

1. Intraoperative Hypothermia Influencing Factors Collection Form: Collects general information about surgical patients, hypothermia nursing measures, and related influencing factors.
2. 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.
3. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Characteristics and Risk Factors of Intraoperative Hypothermia in Adults: A Multicenter Prospective Observational Clinical Study.
   Zhang H, Gao X, Ke W, Wang Z, et al · · 2025 · PMID 41517281 · DOI 10.3390/jcm15010031