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Goal-Directed Temperature Management During Prolonged Abdominal Surgery

2026年10月1日 更新者：Kozlov Valentin Sergeevich、The Leningrad Regional Clinical Hospital

Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study

During long operations on the abdomen, patients often get cold. Doctors call this perioperative hypothermia. Even a small drop in body temperature can cause problems, such as more bleeding, wound infection, and a longer stay in hospital.

To keep patients warm during surgery, doctors usually blow warm air over the body through a special blanket. However, the fluids that patients receive through a vein during surgery are normally at room temperature. These cool fluids may lower the body temperature from the inside.

This study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.

Everyone taking part receives warm air blown over the body. In addition, one group receives fluids into a vein at room temperature, about 23 °C, which is the usual practice. The other group receives the same fluids warmed to 39 °C by a special device just before the fluid enters the vein.

Participants are placed into one of the two groups by chance, like flipping a coin. Because of the nature of the treatment, the doctors caring for the patient know which group the patient is in.

The researchers measure body temperature before, during, and at the end of surgery. They also record blood pressure, the medicines used to support blood pressure, the amount of fluid given, the amount of urine produced, and blood tests taken on the day after surgery.

This is a pilot study. Its main purpose is to find out whether a larger study would be possible. The researchers want to learn how many patients can be enrolled, whether the treatment can be given exactly as planned, and how complete the collected information is. The results will be used to plan a larger study.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Design and setting.

Single-centre, randomised, parallel-group, open-label pilot trial conducted at a regional clinical hospital in Saint Petersburg, Russian Federation. Participants are allocated in a 1:1 ratio to a control group or a study group.

Anaesthesia and warming protocol.

All participants receive general anaesthesia according to a standardised institutional protocol, and ambient operating room temperature is kept constant. In both groups, forced-air warming is applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery. In the control group, balanced crystalloid solutions are stored at 23 °C and infused without additional warming. In the study group, the same solutions are actively warmed to a target temperature of 39 °C using a medical fluid warmer positioned as close as possible to the venous access site.

Measurements.

Axillary and oesophageal temperature are recorded before induction of anaesthesia, hourly during surgery, and at transfer to the intensive care unit. Haemodynamic variables, the use and infusion rate of norepinephrine, intraoperative crystalloid volume and urine output are recorded throughout surgery. Stroke volume, cardiac output and extracellular fluid volume are assessed by tetrapolar impedance rheography. Base excess, plasma lactate, C-reactive protein and the SOFA score are recorded on the first postoperative day.

Randomisation and allocation concealment.

The allocation sequence is generated using random number tables. Allocation is concealed by sequentially numbered, sealed, opaque envelopes, opened after eligibility is confirmed and written informed consent is obtained. Blinding of the anaesthesia team is not feasible because of the nature of the intervention.

Withdrawal criteria.

Participants are withdrawn from analysis in case of withdrawal of informed consent, errors in data recording, or intraoperative change in the extent of the planned surgical procedure.

Feasibility assessment.

In addition to the clinical outcome measures, the following feasibility parameters are recorded: the proportion of screened patients who are eligible and randomised, the proportion of eligible patients who consent, adherence to the allocated intervention, the proportion of randomised participants with analysable data, and completeness of data for the primary outcome measure. These parameters will be used to determine whether a definitive multicentre trial is feasible and to inform its sample size.

研究类型

介入性

注册 (估计的)

61

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 俄罗斯
      • Saint Petersburg、俄罗斯、194291
        • 招聘中
        • The Leningrad Regional Clinical Hospital
        • 接触：
        • 副研究员：
          • Alexey S Rumyantsev-Aleksandrov, MD
        • 首席研究员：
          • Valentin S Kozlov, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Signed written informed consent
  • Age 18 years or older
  • Scheduled abdominal surgery with an expected duration of at least 3 hours

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • End-stage chronic somatic disease
  • Axillary temperature above 37.0 °C before surgery
  • Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury
  • Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology
  • Active infection before surgery

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control group

Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of balanced crystalloid solutions stored at 23 °C and administered without additional warming.
设备：Forced-air warming

Forced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.

其他名称：
  • WarmTouch WT-5900
其他：Unwarmed intravenous fluids

Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.
实验性的：Study group

Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of the same balanced crystalloid solutions actively warmed to a target temperature of 39 °C by a medical fluid warmer positioned as close as possible to the venous access site.
设备：Forced-air warming

Forced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.

其他名称：
  • WarmTouch WT-5900
设备：Intravenous fluid warming

Balanced crystalloid solutions actively warmed to a target temperature of 39 °C using a medical fluid warmer; the infusion line is placed inside the heating element as close as possible to the venous access site.

其他名称：
  • IRIS medical fluid warmer

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Core body temperature at admission to the intensive care unit
大体时间：At transfer to the intensive care unit, up to 12 hours after skin incision

Oesophageal temperature measured at the time of transfer of the participant from the operating room to the intensive care unit, in degrees Celsius.
At transfer to the intensive care unit, up to 12 hours after skin incision

次要结果测量

结果测量
措施说明
大体时间
Perioperative axillary temperature
大体时间：Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours

Axillary temperature measured with a contact thermometer. Measured in degrees Celsius.
Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours
Perioperative oesophageal temperature
大体时间：Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours

Core temperature measured with an oesophageal probe. Measured in degrees Celsius.
Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours
Proportion of participants requiring norepinephrine infusion
大体时间：Intraoperative period, up to 12 hours

Number of participants who received an intraoperative norepinephrine infusion, divided by the number of participants analysed in the group, expressed as a percentage.
Intraoperative period, up to 12 hours
Time from skin incision to initiation of norepinephrine infusion
大体时间：Intraoperative period, up to 12 hours

Interval between skin incision and the start of norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in minutes.
Intraoperative period, up to 12 hours
Norepinephrine infusion rate
大体时间：Intraoperative period, up to 12 hours

Rate of intraoperative norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in micrograms per kilogram per minute.
Intraoperative period, up to 12 hours
Volume of intraoperative crystalloid infusion
大体时间：From skin incision to end of surgery, up to 12 hours

Total volume of balanced crystalloid solutions administered intravenously during surgery. Measured in millilitres.
From skin incision to end of surgery, up to 12 hours
Intraoperative urine output
大体时间：From skin incision to end of surgery, up to 12 hours

Total volume of urine collected during surgery. Measured in millilitres.
From skin incision to end of surgery, up to 12 hours
Stroke volume measured by tetrapolar impedance rheography
大体时间：From before induction of anaesthesia, hourly during surgery, up to 12 hours

Stroke volume assessed non-invasively by tetrapolar impedance rheography. Measured in millilitres.
From before induction of anaesthesia, hourly during surgery, up to 12 hours
Cardiac output measured by tetrapolar impedance rheography
大体时间：From before induction of anaesthesia, hourly during surgery, up to 12 hours

Cardiac output assessed non-invasively by tetrapolar impedance rheography. Measured in litres per minute.
From before induction of anaesthesia, hourly during surgery, up to 12 hours
Change in extracellular fluid volume measured by tetrapolar impedance rheography
大体时间：From start of surgery to end of surgery, up to 12 hours

Relative change in extracellular fluid volume assessed by tetrapolar impedance rheography. Expressed as a percentage.
From start of surgery to end of surgery, up to 12 hours
Base excess in venous blood
大体时间：Postoperative day 1

Base excess determined by venous blood gas analysis. Measured in millimoles per litre.
Postoperative day 1
Plasma lactate concentration
大体时间：Postoperative day 1

Lactate concentration determined in venous blood. Measured in millimoles per litre.
Postoperative day 1
Serum C-reactive protein concentration
大体时间：Postoperative day 1

C-reactive protein concentration determined in venous blood. Measured in milligrams per litre.
Postoperative day 1
Total SOFA score
大体时间：Postoperative day 1

Sequential Organ Failure Assessment score, calculated as the sum of six organ system subscores. Total score ranges from 0 to 24, with higher scores indicating greater organ dysfunction.
Postoperative day 1

其他结果措施

结果测量
措施说明
大体时间
Proportion of screened participants who were randomised
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants divided by the number of patients screened for eligibility, expressed as a percentage.
From start of enrolment through study completion, up to 32 months
Proportion of eligible participants who provided informed consent
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of participants who provided written informed consent divided by the number of patients who met the eligibility criteria, expressed as a percentage.
From start of enrolment through study completion, up to 32 months
Recruitment rate
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants per month of enrolment.
From start of enrolment through study completion, up to 32 months
Adherence to the allocated intervention
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants who received the allocated intervention in full, divided by the number of randomised participants, expressed as a percentage.
From start of enrolment through study completion, up to 32 months
Proportion of randomised participants with analysable data
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants whose data were available for analysis of the clinical outcome measures, divided by the number of randomised participants, expressed as a percentage.
From start of enrolment through study completion, up to 32 months
Completeness of data for the primary outcome measure
大体时间：From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of analysed participants with a recorded value of the primary outcome measure, divided by the number of analysed participants, expressed as a percentage.
From start of enrolment through study completion, up to 32 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Leningrad Regional Clinical Hospital

合作者

North-Western State Medical University named after I.I.Mechnikov

调查人员

  • 首席研究员：Valentin S Kozlov, MD、The Leningrad Regional Clinical Hospital
  • 首席研究员：Ionas S Simutis, MD, Dsc、North-Western State Medical University named after I.I.Mechnikov

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月15日

初级完成 (估计的)

2027年4月15日

研究完成 (估计的)

2027年6月15日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LOKB-TTM-2024-01
  • Protocol N. 9 dated 23.10.2024 (其他标识符：Local Ethics Committee, North-Western State Medical University named after I.I. Mechnikov)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request to the corresponding author, following approval of a methodologically sound proposal.

IPD 共享时间框架

Beginning 6 months after publication of the main results and ending 3 years thereafter.

IPD 共享访问标准

Requests should be directed to the corresponding author and will be evaluated on the basis of scientific merit. Data will be shared after approval of a proposal and completion of a data access agreement.

研究数据/文件

  1. 研究协议
    信息标识符：OSF.IO/4GCFX
    信息评论：

    Study protocol summary, version 1.0

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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