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

NCT06836245 | Enrolling By Invitation

• 1 other identifier: 016-03-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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. 1.Risk factor assessment
2. 2.Use of the adult intraoperative hypothermia risk assessment scale
3. 3.Core body temperature measurement
4. 4.Prevention strategies for high-risk patients
5. 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.
6. 6.Intraoperative Hypothermia Influencing Factors Collection Form: Collects general information about surgical patients, hypothermia nursing measures, and related influencing factors.
7. 7.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.
8. 8.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.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• Surgical patient body temperature.

  2024.9.15-2025.2.30

Interventions

Measure the patient's body temperature intraoperatively using instruments OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients from all departments.

You may qualify if:

• Surgical patients aged ≥18 years;

You may not qualify if:

• 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.)

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: September 15, 2024
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)