Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer (CWSRIH-HCC)

January 9, 2025 updated by: Ou Jiang, The First People's Hospital of Neijiang

Warming with a Composite Warming Strategy Reduces Intraoperative Hypothermia in Patients Undergoing Open Hepatectomy for Liver Cancer: a Randomized Controlled Study

The composite warming strategy has a certain effect on preventing hypothermia during cancer liver resection surgery. This study aims to explore the application of compound warming strategy in perioperative nursing of cancer liver resection.

This study will compare two groups: the control group using perioperative forced warming measures, and the experimental group using a composite warming strategy.

Main objective: Intraoperative temperature changes Secondary objective: incidence of complications The investigators' investigated the practicality and effectiveness of a combined warming strategy in open liver resection surgery. In addition, the investigators also conducted a quantitative correlation study on the incidence of hypothermia during the surgical process. This provides evidence-based guidance for the prevention of hypothermia during surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Title: Warming with a Composite Warming Strategy Reduces Intraoperative Hypothermia in Patients Undergoing Open Hepatectomy for Liver Cancer: A Randomized Controlled Study Background: Perioperative hypothermia is a clinical condition characterized by a core body temperature dropping below 36 ° C during the perioperative period, which is a common complication in anesthesia and open abdominal surgery. This state can lead to various perioperative complications, including but not limited to surgical site infections, arrhythmia, and cardiac obstruction.

Main objective: Intraoperative temperature changes Secondary objective: incidence of complications Meaning:The investigators' investigated the practicality and effectiveness of a combined warming strategy in open liver resection surgery. In addition, the investigators also conducted a quantitative correlation study on the incidence of hypothermia during the surgical process. This provides evidence-based guidance for the prevention of hypothermia during surgery. In addition, the investigators also conducted a quantitative correlation study on the incidence of hypothermia during the surgical process.

Innovation: The innovation of this article lies in the first verification of the practicality and effectiveness of the composite warming strategy in open liver resection surgery.

Expected outcome: The practical and effective use of a combined warming strategy in open liver resection surgery. In terms of anesthesia duration, blood loss, fluid replacement, and PACU observation duration, the composite warming strategy may have better results than the forced air warming system.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Neijiang, Sichuan, China, 641000
        • The First People's Hospital of Neijiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18 and 75 years.
  • Scheduled for elective open hepatectomy to treat hepatocellular carcinoma, confirmed by preoperative biopsy or imaging.
  • Adequate liver function (Child-Pugh score A or B).
  • American Society of Anesthesiologists (ASA) physical status classification of I, II, or well-controlled III.
  • Informed consent provided for participation.

Exclusion Criteria:

  • Aged under 18 or over 75 years.
  • Metastatic liver disease or emergency liver surgery required.
  • Chronic analgesic use that could interfere with pain assessment.
  • Participation in another clinical trial within the past 30 days.
  • Contraindications to warming devices (e.g., certain skin conditions or advanced peripheral vascular disease).
  • Pregnant or lactating.
  • Presence of an implantable device (e.g., pacemakers or defibrillators) that could be affected by warming strategies.
  • Cognitive impairment or psychiatric disorders affecting study understanding or informed consent.
  • Use of medications/substances impacting thermoregulation (e.g., illicit drugs, alcohol abuse, antipyretics).
  • History of malignancies other than liver cancer affecting survival or perioperative risk.
  • Recent history (within six months) of myocardial infarction or cerebrovascular accident.
  • Uncontrolled diabetes mellitus or other significant endocrine disorders.
  • Severe anemia (hemoglobin below a predetermined threshold).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group: perioperative mandatory warming measures
Procedure: perioperative mandatory warming measures
perioperative mandatory warming measures
Experimental: Compound heating strategy
Procedure: Compound heating strategy
After the surgery begins, a temperature monitoring device (disposable medical temperature sensor provided by the limited company) is inserted into the patient's nasopharynx to record the core temperature, while activating the water blanket and forced air heating system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative temperature changes
Time Frame: At the beginning of the surgery; every 5 minutes during surgery; after the surgery is completed.
Intraoperative temperature changes: After the surgery begins, a temperature monitoring device (disposable medical temperature sensor provided by the limited company) is inserted into the patient's nasopharynx to record the core temperature, while activating the water blanket and forced air.
At the beginning of the surgery; every 5 minutes during surgery; after the surgery is completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Neijiang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-lunshenpi-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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