HCCCWSRIH-HCCNCT06766773
Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer
A study testing Compound heating strategy and perioperative mandatory warming measures in people with HCC, run by The First People's Hospital of Neijiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- Compound heating strategy and perioperative mandatory warming measures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HCC
- Being tested
- Compound heating strategy, perioperative mandatory warming measures
- Keywords
- Intraoperative hypothermia, Open hepatectomy for liver cancer, Composite warming strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound heating strategyProcedure or surgery
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 measuresProcedure or surgery
perioperative mandatory warming measures
| Study group | Role | What they receive |
|---|---|---|
| Control group: perioperative mandatory warming measures | Placebo comparator | Not described Receives: Procedure: perioperative mandatory warming measures |
| Compound heating strategy | Experimental | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the beginning of the surgery; every 5 minutes during surgery; after the surgery is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jan 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Neijiang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Jiang, The First People's Hospital of Neijiang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766773
- Sponsor's protocol ID
- 2021-lunshenpi-32
- Acronym
- CWSRIH-HCC
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24720346Andrzejowski 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.
PubMed 18820248Kvolik 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.
PubMed 19394816Kanikarla 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.
PubMed 34367949Staikou 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.
PubMed 19932906Birgin 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.
PubMed 34638285Xu 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.
PubMed 31145350Simegn 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.
PubMed 34840773Diaz 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.
PubMed 20331336Balki 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.
PubMed 33079867Yi 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.
PubMed 39993117
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warming With a Composite Warming Strategy Reduces Intraoperative Hypothermia in Patients Undergoing Open Hepatectomy for Liver Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06766773
- Acronym / sponsor ID
- CWSRIH-HCC / 2021-lunshenpi-32
- Conditions
- HCC
- Keywords
- Intraoperative hypothermia, Open hepatectomy for liver cancer, Composite warming strategy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First People's Hospital of NeijiangUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: perioperative mandatory warming measures | Placebo comparator | Procedure: perioperative mandatory warming measures |
| Compound heating strategy | Experimental | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound heating strategyAfter 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. | Procedure or surgery | – |
| perioperative mandatory warming measuresperioperative mandatory warming measures | Procedure or surgery | Control group: perioperative mandatory warming measures |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Results publication: PubMed 24720346John 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.
- Results publication: PubMed 18820248Andrzejowski 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.
- Results publication: PubMed 19394816Kvolik 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.
- Results publication: PubMed 34367949Kanikarla 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.
- Results publication: PubMed 19932906Staikou 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.
- Results publication: PubMed 34638285Birgin 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.
- Results publication: PubMed 31145350Xu 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.
- Results publication: PubMed 34840773Simegn 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.
- Results publication: PubMed 20331336Diaz 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.
- Results publication: PubMed 33079867Balki 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.
- Derived from this study: PubMed 39993117Yi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound heating strategy and perioperative mandatory warming measures in people with HCC, run by The First People's Hospital of Neijiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative temperature changes (time frame: At the beginning of the surgery; every 5 minutes during surgery; after the surgery is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766773, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.