Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer
NCT ID: NCT06766773
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2020-01-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group: perioperative mandatory warming measures
perioperative mandatory warming measures
perioperative mandatory warming measures
Compound heating strategy
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.
Interventions
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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.
perioperative mandatory warming measures
perioperative mandatory warming measures
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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The First People's Hospital of Neijiang
OTHER
Responsible Party
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Ou Jiang
Director of Cancer Center
Locations
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The First People's Hospital of Neijiang
Neijiang, Sichuan, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2021-lunshenpi-32
Identifier Type: -
Identifier Source: org_study_id
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