Clinical trial NCT06766773: Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer
Official title: Warming with a Composite Warming Strategy Reduces Intraoperative Hypothermia in Patients Undergoing Open Hepatectomy for Liver Cancer: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HCC
Keywords: Intraoperative hypothermia
Open hepatectomy for liver cancer
Composite warming strategy
Lead sponsor: The First People's Hospital of Neijiang
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Intraoperative temperature changes
timeFrame: At the beginning of the surgery; every 5 minutes during surgery; after the surgery is completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Neijiang
country: China
facility: The First People's Hospital of Neijiang
state: Sichuan
Study officials:
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