跳至主要内容
临床试验/NCT06836245
NCT06836245Enrolling By Invitation不适用

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

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
5,000
试验地点
1
主要终点
Surgical patient body temperature.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria for patients:
  • •Surgical patients aged ≥18 years;
  • •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.)

排除标准

  • •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:
  • •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.
  • •Special intraoperative temperature management refers to additional or bundled hypothermia protection measures added to the routine hypothermic care in the operating room.)

结局指标

主要结局

Surgical patient body temperature.

时间窗: 2024.9.15-2025.2.30

次要结局

未报告次要终点

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Sponsor

研究点 (1)

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