Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer

NCT06766773 | Active Not Recruiting DMC

• 1 other identifier: 2021-lunshenpi-32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC

Keywords

Intraoperative hypothermia; Open hepatectomy for liver cancer; Composite warming strategy

Outcome Measures

Primary Outcomes (1)

• Intraoperative temperature changes

  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.

Study Arms (2)

Control group: perioperative mandatory warming measures

PLACEBO COMPARATOR

Procedure: perioperative mandatory warming measures

Compound heating strategy

EXPERIMENTAL

Procedure: Compound heating strategy

Interventions

Compound heating strategy PROCEDURE

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.

Compound heating strategy

perioperative mandatory warming measures PROCEDURE

perioperative mandatory warming measures

Control group: perioperative mandatory warming measures

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First People's Hospital of Neijiang: lead

Study Sites (1)

The First People's Hospital of Neijiang

Neijiang, Sichuan, 641000, China

Location

Related Publications (11)

• John M, Ford J, Harper M. Peri-operative warming devices: performance and clinical application. Anaesthesia. 2014 Jun;69(6):623-38. doi: 10.1111/anae.12626. Epub 2014 Apr 10.

  PMID: 24720346 BACKGROUND

• Andrzejowski J, Hoyle J, Eapen G, Turnbull D. Effect of prewarming on post-induction core temperature and the incidence of inadvertent perioperative hypothermia in patients undergoing general anaesthesia. Br J Anaesth. 2008 Nov;101(5):627-31. doi: 10.1093/bja/aen272. Epub 2008 Sep 26.

  PMID: 18820248 BACKGROUND

• Kvolik S, Jukic M, Matijevic M, Marjanovic K, Glavas-Obrovac L. An overview of coagulation disorders in cancer patients. Surg Oncol. 2010 Mar;19(1):e33-46. doi: 10.1016/j.suronc.2009.03.008. Epub 2009 Apr 25.

  PMID: 19394816 BACKGROUND

• Kanikarla Marie P, Fowlkes NW, Afshar-Kharghan V, Martch SL, Sorokin A, Shen JP, Morris VK, Dasari A, You N, Sood AK, Overman MJ, Kopetz S, Menter DG. The Provocative Roles of Platelets in Liver Disease and Cancer. Front Oncol. 2021 Jul 21;11:643815. doi: 10.3389/fonc.2021.643815. eCollection 2021.

  PMID: 34367949 BACKGROUND

• Staikou C, Paraskeva A, Drakos E, Anastassopoulou I, Papaioannou E, Donta I, Kontos M. Impact of graded hypothermia on coagulation and fibrinolysis. J Surg Res. 2011 May 1;167(1):125-30. doi: 10.1016/j.jss.2009.07.037. Epub 2009 Aug 26.

  PMID: 19932906 BACKGROUND

• Birgin E, Kaslow SR, Hetjens S, Correa-Gallego C, Rahbari NN. Minimally Invasive versus Open Liver Resection for Stage I/II Hepatocellular Carcinoma. Cancers (Basel). 2021 Sep 25;13(19):4800. doi: 10.3390/cancers13194800.

  PMID: 34638285 BACKGROUND

• Xu H, Xu G, Ren C, Liu L, Wei L. Effect of forced-air warming system in prevention of postoperative hypothermia in elderly patients: A Prospective controlled trial. Medicine (Baltimore). 2019 May;98(22):e15895. doi: 10.1097/MD.0000000000015895.

  PMID: 31145350 BACKGROUND

• Simegn GD, Bayable SD, Fetene MB. Prevention and management of perioperative hypothermia in adult elective surgical patients: A systematic review. Ann Med Surg (Lond). 2021 Nov 14;72:103059. doi: 10.1016/j.amsu.2021.103059. eCollection 2021 Dec.

  PMID: 34840773 BACKGROUND

• Diaz M, Becker DE. Thermoregulation: physiological and clinical considerations during sedation and general anesthesia. Anesth Prog. 2010 Spring;57(1):25-32; quiz 33-4. doi: 10.2344/0003-3006-57.1.25.

  PMID: 20331336 BACKGROUND

• Balki I, Khan JS, Staibano P, Duceppe E, Bessissow A, Sloan EN, Morley EE, Thompson AN, Devereaux B, Rojas C, Rojas C, Siddiqui N, Sessler DI, Devereaux PJ. Effect of Perioperative Active Body Surface Warming Systems on Analgesic and Clinical Outcomes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2020 Nov;131(5):1430-1443. doi: 10.1213/ANE.0000000000005145.

  PMID: 33079867 BACKGROUND

• Yi N, Wang Z, Cui R. Warming with a composite warming strategy reduces intraoperative hypothermia in patients undergoing open hepatectomy for liver cancer: A randomized controlled study. Medicine (Baltimore). 2025 Feb 21;104(8):e41616. doi: 10.1097/MD.0000000000041616.

  PMID: 39993117 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: January 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)