Clinical trial NCT06836245: Multicenter Application of the Intraoperative Hypothermia Risk Prediction Scale and the Distribution of Risk Factor Characteristics in Surgical Patients
Official title: Multicenter Application of the Intraoperative Hypothermia Risk Prediction Scale and the Distribution of Risk Factor Characteristics in Surgical Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypothermia
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients from all departments.

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.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for patients:

1. Surgical patients aged ≥18 years;
2. 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.)

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.)

Primary outcomes:
measure: Surgical patient body temperature.
timeFrame: 2024.9.15-2025.2.30
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei
state: Hubei
Study officials:
References: