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

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Enrolling by Invitation
  2. Minor Completion date: Apr 30, 2025 to Jul 30, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06836245
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Hypothermia
Enrollment 5,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov