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

NCT ID: NCT06836245

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-07-30

Brief 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. 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.

Conditions

Hypothermia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Measure the patient's body temperature intraoperatively using instruments

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Surgical patients aged ≥18 years;

Exclusion Criteria

1. Patients undergoing local anesthesia surgery;

2. Surgical patients requiring controlled hypothermic treatment or special intraoperative temperature management;

3. Surgical patients whose underlying disease affects the body's temperature regulation;

4. 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

016-03-01

Identifier Type: -

Identifier Source: org_study_id