Inflammatory ResponseWARM-CHOLNCT07232251
Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy
A study testing Standard Active Warming Blanket, Intravenous Warmer Group and External Warmer Group in people with Inflammatory Response and Perioperative Hypothermia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Response, Perioperative Hypothermia, Laparoscopic Cholecystectomy
- What is being tested?
- Standard Active Warming Blanket, Intravenous Warmer Group and External Warmer Group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA (American Society of Anesthesiologists) physical status I-III.
- Age between 18 and 65 years.
- Willingness and ability to provide written informed consent.
Who cannot join
- ASA IV-V patients.
- Emergency surgery requirement.
- Preoperative fever (>38.0 °C) or hypothermia (<36.0 °C).
- Operation duration <60 minutes or >180 minutes.
- Endocrine/metabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).
- Active infection/sepsis or systemic infection within past 2 weeks.
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- Chronic immunosuppressive therapy (e.g., ≥10 mg/day prednisolone equivalent ≥2 weeks or biological agents in the past month).
- Hematologic disorders (e.g., leukemia, aplastic anemia, myeloproliferative disorders) or abnormal blood counts (platelet <100 ×10⁹/L, leukocyte <3 ×10⁹/L).
- Active malignancy or ongoing chemotherapy/radiotherapy in last 3 months.
- Severe organ failure (Child-Pugh C liver, eGFR <30 mL/min/1.73 m² or dialysis, NYHA III-IV heart failure, GOLD III-IV COPD).
- Coagulopathy or uncontrolled antithrombotic therapy.
- Pregnancy or lactation.
- Conversion from laparoscopic to open surgery.
- Non-adherence to assigned warming protocol.
- Inability to place esophageal temperature probe or unreliable temperature monitoring.
- Intraoperative hemodynamic instability requiring prolonged vasopressor support or blood transfusion.
- Missing or incomplete preoperative or postoperative CBC preventing calculation of inflammatory indices.
- Withdrawal of consent or loss to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Intraoperative Warming Techniques on Core Body Temperature and Hematologic Inflammatory Indices (SII, NLR, PLR, LMR) in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic inflammatory responses remain unclear.
This randomized controlled clinical trial aims to evaluate the effects of different intraoperative warming methods on hematologic inflammatory indices - including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) - in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Read more
A total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied:
Control Group: No active warming applied.
Forced-Air Warming (FAW) Group: Warming blanket system used throughout surgery.
Fluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia.
Combined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously.
Core body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices.
The primary objective is to determine whether active intraoperative warming techniques modulate postoperative inflammatory markers compared to no warming. Secondary outcomes include intraoperative temperature trends, recovery times, and the incidence of hypothermia-related complications.
The results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.
Read the detailed description
Unintended perioperative hypothermia (core temperature <36°C) commonly occurs during laparoscopic surgeries due to anesthesia-induced thermoregulatory impairment, pneumoperitoneum, and cold ambient conditions. Even mild decreases in body temperature can impair coagulation, delay drug metabolism, and alter immune function. Maintaining normothermia is therefore critical for improving surgical outcomes.
While both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.
This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.
Eligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.
Participants will be randomly assigned to one of four groups:
Group C (Control): No active warming; standard passive insulation only.
Group FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.
Group FW (Fluid Warming): Intravenous fluids administered through a warming device.
Group CF (Combined Warming): Both forced-air warming and fluid warming used together.
Standardized anesthesia induction and maintenance protocols will be followed for all patients. Core temperature will be continuously monitored via nasopharyngeal probe. Temperature, hemodynamic parameters, and perioperative variables will be recorded at fixed intervals.
Blood samples will be obtained at two time points - preoperatively and at 24 hours postoperatively - for complete blood count analysis. The inflammatory indices (NLR, PLR, SII) will be calculated and compared among groups.
Primary Outcome:
Postoperative change in hematologic inflammatory indices [(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)].
Secondary Outcomes:
Intraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.
Statistical analyses will be performed using SPSS. Continuous variables will be expressed as mean ± SD or median (IQR) and analyzed using ANOVA or Kruskal-Wallis test, as appropriate. Categorical data will be compared using Chi-square or Fisher's exact test. A p-value <0.05 will be considered statistically significant.
This study seeks to clarify whether intraoperative thermal management strategies influence the systemic inflammatory response, potentially guiding clinicians toward the most effective warming method to enhance recovery and minimize postoperative complications.
- Conditions
- Inflammatory Response, Perioperative Hypothermia, Laparoscopic Cholecystectomy, Surgical Stress Response
- Being tested
- Standard Active Warming Blanket, Intravenous Warmer Group, External Warmer Group
- Keywords
- Intraoperative warming, Forced-air warming, Combined warming, Hypothermia prevention, Fluid warming, Hematologic inflammatory indices, Neutrophil-to-lymphocyte ratio (NLR), Platelet-to-lymphocyte ratio (PLR), Systemic immune-inflammation index (SII), Laparoscopic surgery, Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Active Warming BlanketDevice
Also called MEDWARM W-300/A 150-MS/A 96116-K4656
An active blanket set at 38°C is used to maintain the patient's body temperature throughout the operation. Body areas outside the surgical field are covered with passive drapes. No supplemental heating is used.
Intravenous Warmer GroupDevice
Also called IV Fluid Warmer, Portable Flotherm QW3 Fluid And Blood Warmer
All intravenous fluids administered during the operation are administered via a fluid warming device at 38°C. All standard practices continue in the control group.
External Warmer GroupDevice
Also called External Forced-Air Warming Device, 3M Bair Hugger 700 Series
A special drape is placed over the upper extremities and thorax, and the patient is connected to an external warm air device at 38°C throughout the operation. All standard practices continue in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Patients receive standard intraoperative warming with 38 °C set active warming blanket. Surgical field outside the blanket is covered with passive drapes. No additional warming interventions are applied. (standart care) Receives: Device: Standard Active Warming Blanket |
| Intravenous Warmer Group | Active comparator | All standard procedures performed in the control group are followed. Additionally, all intravenous fluids administered during the operation are warmed to 38°C with a fluid warmer. Receives: Device: Standard Active Warming Blanket; Device: Intravenous Warmer Group |
| External Warmer Group | Active comparator | All standard approaches used in the control group are performed. Additionally, a special drape is placed over the upper extremities and thorax, which is connected to a 3M Bair Hugger 700 Series device and warmed to 38°C. Receives: Device: Standard Active Warming Blanket; Device: External Warmer Group |
| Combined Warming Group (Intravenous + External) | Active comparator | All standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity/thorax. Receives: Device: Standard Active Warming Blanket; Device: Intravenous Warmer Group; Device: External Warmer Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Core Body Temperature
Core body temperature will be continuously monitored via esophageal probe throughout laparoscopic cholecystectomy. The primary outcome is the mean core temperature at the end of surgery, comparing the four intraoperative warming strategies (Control, IV warming, External warming, Combined IV + External warming).
Measured: Intraoperative, measured continuously and recorded at the end of surgery (1 time point)
Secondary outcomes (4)
Systemic Immune-Inflammation Index (SII)
SII will be calculated using neutrophil, lymphocyte, and platelet counts from complete blood counts to assess systemic inflammatory response.
Measured: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Neutrophil-to-Lymphocyte Ratio (NLR)
NLR will be calculated from complete blood counts to evaluate the balance between acute inflammation and immune function.
Measured: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Platelet-to-Lymphocyte Ratio (PLR)
PLR will be calculated from platelet and lymphocyte counts to assess postoperative inflammatory and thrombotic response.
Measured: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Lymphocyte-to-Monocyte Ratio (LMR)
LMR will be calculated from lymphocyte and monocyte counts to evaluate immune regulation and inflammatory balance after surgery.
Measured: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completion7 Oct 2026
- Study completion8 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this prospective, randomized, controlled trial, patients will be equally assigned to four groups: Control Group (standard blanket + passive blanket) IV Warmer Group (standard care + intravenous fluid warmer) External Warmer Group (standard care + external warmer) Combined Warmer Group (standard care + intravenous fluid warmer + external warmer)
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Cem ÇELİK, Ataturk University
- Investigators
- Erkan Cem Çelik, doctor, Principal investigator, Ataturk University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232251
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/657
- Other IDs
- 2025/2
- Acronym
- WARM-CHOL
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data (demographics, perioperative temperature, hematologic inflammatory indices) will be made available upon reasonable request to qualified researchers after publication of the primary study results.
Publications
Wang J, Bi Y, Ma J, He Y, Liu B. Association of Preoperative Neutrophil-to-Lymphocyte Ratio with Postoperative Acute Kidney Injury and Mortality Following Major Noncardiac Surgeries. World J Surg. 2023 Apr;47(4):948-961. doi: 10.1007/s00268-022-06878-2. Epub 2023 Jan 21.
PubMed 36681771Jiao Y, Zhang X, Liu M, Sun Y, Ma Z, Gu X, Gu W, Zhu W. Systemic immune-inflammation index within the first postoperative hour as a predictor of severe postoperative complications in upper abdominal surgery: a retrospective single-center study. BMC Gastroenterol. 2022 Aug 27;22(1):403. doi: 10.1186/s12876-022-02482-9.
PubMed 36030214Gao Y, Guo W, Cai S, Zhang F, Shao F, Zhang G, Liu T, Tan F, Li N, Xue Q, Gao S, He J. Systemic immune-inflammation index (SII) is useful to predict survival outcomes in patients with surgically resected esophageal squamous cell carcinoma. J Cancer. 2019 Jun 2;10(14):3188-3196. doi: 10.7150/jca.30281. eCollection 2019.
PubMed 31289589Xu H, Wang Z, Guan X, Lu Y, Malone DC, Salmon JW, Ma A, Tang W. Safety of intraoperative hypothermia for patients: meta-analyses of randomized controlled trials and observational studies. BMC Anesthesiol. 2020 Aug 15;20(1):202. doi: 10.1186/s12871-020-01065-z.
PubMed 32799802Zheng W, Huang B, Bao L, Wang J, Jin J. Comparing warming strategies to reduce hypothermia and shivering in elderly abdominal or pelvic surgery patients: a network meta-analysis. Sci Rep. 2025 Jul 1;15(1):22356. doi: 10.1038/s41598-025-04644-7.
PubMed 40595941Ji N, Wang J, Li X, Shang Y. Strategies for perioperative hypothermia management: advances in warming techniques and clinical implications: a narrative review. BMC Surg. 2024 Dec 30;24(1):425. doi: 10.1186/s12893-024-02729-0.
PubMed 39736577McSwain J. Perioperative hypothermia: Causes, consequences and treatment. World Journal of Anesthesiology. 11/27 2015;4:58. doi:10.5313/wja.v4.i3.58
Rauch S, Miller C, Brauer A, Wallner B, Bock M, Paal P. Perioperative Hypothermia-A Narrative Review. Int J Environ Res Public Health. 2021 Aug 19;18(16):8749. doi: 10.3390/ijerph18168749.
PubMed 34444504Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
PubMed 19137808Ruetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.
PubMed 30459033
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Intraoperative Warming Techniques on Core Body Temperature and Hematologic Inflammatory Indices (SII, NLR, PLR, LMR) in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07232251
- Acronym / sponsor ID
- WARM-CHOL / B.30.2.ATA.0.01.00/657
- Conditions
- Inflammatory Response, Perioperative Hypothermia, Laparoscopic Cholecystectomy, Surgical Stress Response
- Keywords
- Intraoperative warming, Forced-air warming, Combined warming, Hypothermia prevention, Fluid warming, Hematologic inflammatory indices, Neutrophil-to-lymphocyte ratio (NLR), Platelet-to-lymphocyte ratio (PLR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 7 Oct 2026 (actual)
- Study completion
- 8 Oct 2026 (actual)
- First posted
- 18 Nov 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.
Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic inflammatory responses remain unclear.
This randomized controlled clinical trial aims to evaluate the effects of different intraoperative warming methods on hematologic inflammatory indices - including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) - in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied:
Control Group: No active warming applied.
Forced-Air Warming (FAW) Group: Warming blanket system used throughout surgery.
Fluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia.
Combined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously.
Core body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices.
The primary objective is to determine whether active intraoperative warming techniques modulate postoperative inflammatory markers compared to no warming. Secondary outcomes include intraoperative temperature trends, recovery times, and the incidence of hypothermia-related complications.
The results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.
Detailed description
Unintended perioperative hypothermia (core temperature <36°C) commonly occurs during laparoscopic surgeries due to anesthesia-induced thermoregulatory impairment, pneumoperitoneum, and cold ambient conditions. Even mild decreases in body temperature can impair coagulation, delay drug metabolism, and alter immune function. Maintaining normothermia is therefore critical for improving surgical outcomes.
While both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.
This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.
Eligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.
Participants will be randomly assigned to one of four groups:
Group C (Control): No active warming; standard passive insulation only.
Group FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.
Group FW (Fluid Warming): Intravenous fluids administered through a warming device.
Group CF (Combined Warming): Both forced-air warming and fluid warming used together.
Standardized anesthesia induction and maintenance protocols will be followed for all patients. Core temperature will be continuously monitored via nasopharyngeal probe. Temperature, hemodynamic parameters, and perioperative variables will be recorded at fixed intervals.
Blood samples will be obtained at two time points - preoperatively and at 24 hours postoperatively - for complete blood count analysis. The inflammatory indices (NLR, PLR, SII) will be calculated and compared among groups.
Primary Outcome:
Postoperative change in hematologic inflammatory indices [(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)].
Secondary Outcomes:
Intraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.
Statistical analyses will be performed using SPSS. Continuous variables will be expressed as mean ± SD or median (IQR) and analyzed using ANOVA or Kruskal-Wallis test, as appropriate. Categorical data will be compared using Chi-square or Fisher's exact test. A p-value <0.05 will be considered statistically significant.
This study seeks to clarify whether intraoperative thermal management strategies influence the systemic inflammatory response, potentially guiding clinicians toward the most effective warming method to enhance recovery and minimize postoperative complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In this prospective, randomized, controlled trial, patients will be equally assigned to four groups: Control Group (standard blanket + passive blanket) IV Warmer Group (standard care + intravenous fluid warmer) External Warmer Group (standard care + external warmer) Combined Warmer Group (standard care + intravenous fluid warmer + external warmer)
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Device: Standard Active Warming BlanketPatients receive standard intraoperative warming with 38 °C set active warming blanket. Surgical field outside the blanket is covered with passive drapes. No additional warming interventions are applied. (standart care) |
| Intravenous Warmer Group | Active comparator | Device: Standard Active Warming Blanket, Device: Intravenous Warmer GroupAll standard procedures performed in the control group are followed. Additionally, all intravenous fluids administered during the operation are warmed to 38°C with a fluid warmer. |
| External Warmer Group | Active comparator | Device: Standard Active Warming Blanket, Device: External Warmer GroupAll standard approaches used in the control group are performed. Additionally, a special drape is placed over the upper extremities and thorax, which is connected to a 3M Bair Hugger 700 Series device and warmed to 38°C. |
| Combined Warming Group (Intravenous + External) | Active comparator | Device: Standard Active Warming Blanket, Device: Intravenous Warmer Group, Device: External Warmer GroupAll standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity/thorax. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA (American Society of Anesthesiologists) physical status I-III.
- Age between 18 and 65 years.
- Willingness and ability to provide written informed consent.
Key exclusion criteria (18 listed)
- ASA IV-V patients.
- Emergency surgery requirement.
- Preoperative fever (>38.0 °C) or hypothermia (<36.0 °C).
- Operation duration <60 minutes or >180 minutes.
- Endocrine/metabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).
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 |
|---|---|---|
| Standard Active Warming BlanketAlso: MEDWARM W-300/A 150-MS/A 96116-K4656An active blanket set at 38°C is used to maintain the patient's body temperature throughout the operation. Body areas outside the surgical field are covered with passive drapes. No supplemental heating is used. | Device | Combined Warming Group (Intravenous + External), Control Group, External Warmer Group, Intravenous Warmer Group |
| Intravenous Warmer GroupAlso: IV Fluid Warmer, Portable Flotherm QW3 Fluid And Blood WarmerAll intravenous fluids administered during the operation are administered via a fluid warming device at 38°C. All standard practices continue in the control group. | Device | Combined Warming Group (Intravenous + External), Intravenous Warmer Group |
| External Warmer GroupAlso: External Forced-Air Warming Device, 3M Bair Hugger 700 SeriesA special drape is placed over the upper extremities and thorax, and the patient is connected to an external warm air device at 38°C throughout the operation. All standard practices continue in the control group. | Device | Combined Warming Group (Intravenous + External), External Warmer Group |
Primary outcome
Postoperative Core Body Temperature
Time frame: Intraoperative, measured continuously and recorded at the end of surgery (1 time point)
Core body temperature will be continuously monitored via esophageal probe throughout laparoscopic cholecystectomy. The primary outcome is the mean core temperature at the end of surgery, comparing the four intraoperative warming strategies (Control, IV warming, External warming, Combined IV + External warming).
4 secondary outcomes
Systemic Immune-Inflammation Index (SII)
Time frame: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Lymphocyte-to-Monocyte Ratio (LMR)
Time frame: Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Results publication: PubMed 36681771Wang J, Bi Y, Ma J, He Y, Liu B. Association of Preoperative Neutrophil-to-Lymphocyte Ratio with Postoperative Acute Kidney Injury and Mortality Following Major Noncardiac Surgeries. World J Surg. 2023 Apr;47(4):948-961. doi: 10.1007/s00268-022-06878-2. Epub 2023 Jan 21.
- Results publication: PubMed 36030214Jiao Y, Zhang X, Liu M, Sun Y, Ma Z, Gu X, Gu W, Zhu W. Systemic immune-inflammation index within the first postoperative hour as a predictor of severe postoperative complications in upper abdominal surgery: a retrospective single-center study. BMC Gastroenterol. 2022 Aug 27;22(1):403. doi: 10.1186/s12876-022-02482-9.
- Results publication: PubMed 31289589Gao Y, Guo W, Cai S, Zhang F, Shao F, Zhang G, Liu T, Tan F, Li N, Xue Q, Gao S, He J. Systemic immune-inflammation index (SII) is useful to predict survival outcomes in patients with surgically resected esophageal squamous cell carcinoma. J Cancer. 2019 Jun 2;10(14):3188-3196. doi: 10.7150/jca.30281. eCollection 2019.
- Results publication: PubMed 32799802Xu H, Wang Z, Guan X, Lu Y, Malone DC, Salmon JW, Ma A, Tang W. Safety of intraoperative hypothermia for patients: meta-analyses of randomized controlled trials and observational studies. BMC Anesthesiol. 2020 Aug 15;20(1):202. doi: 10.1186/s12871-020-01065-z.
- Results publication: PubMed 40595941Zheng W, Huang B, Bao L, Wang J, Jin J. Comparing warming strategies to reduce hypothermia and shivering in elderly abdominal or pelvic surgery patients: a network meta-analysis. Sci Rep. 2025 Jul 1;15(1):22356. doi: 10.1038/s41598-025-04644-7.
- Results publication: PubMed 39736577Ji N, Wang J, Li X, Shang Y. Strategies for perioperative hypothermia management: advances in warming techniques and clinical implications: a narrative review. BMC Surg. 2024 Dec 30;24(1):425. doi: 10.1186/s12893-024-02729-0.
- Results publicationMcSwain J. Perioperative hypothermia: Causes, consequences and treatment. World Journal of Anesthesiology. 11/27 2015;4:58. doi:10.5313/wja.v4.i3.58
- Results publication: PubMed 34444504Rauch S, Miller C, Brauer A, Wallner B, Bock M, Paal P. Perioperative Hypothermia-A Narrative Review. Int J Environ Res Public Health. 2021 Aug 19;18(16):8749. doi: 10.3390/ijerph18168749.
- Results publication: PubMed 19137808Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
- Results publication: PubMed 30459033Ruetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.
- Individual participant dataSharing planned: Yes. De-identified participant data (demographics, perioperative temperature, hematologic inflammatory indices) will be made available upon reasonable request to qualified researchers after publication of the primary study results.
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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.
Erkan Cem Çelik, doctor principal investigator
Ataturk University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Active Warming Blanket, Intravenous Warmer Group and External Warmer Group in people with Inflammatory Response and Perioperative Hypothermia, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 13 Oct 2026. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Core Body Temperature (time frame: Intraoperative, measured continuously and recorded at the end of surgery (1 time point)). 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 NCT07232251, which also lists 10 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 13 Oct 2026.