Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Valentin S Kozlov, MD
- 電話番号：+7-931-250-79-30
- メール：kozlov.vs@47lokb.ru
研究場所
-
-
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Saint Petersburg、ロシア、194291
- 募集
- The Leningrad Regional Clinical Hospital
-
コンタクト：
- Valentin S Kozlov, MD
- 電話番号：+7-931-250-79-30
- メール：kozlov.vs@47lokb.ru
-
副調査官：
- Alexey S Rumyantsev-Aleksandrov, MD
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主任研究者：
- Valentin S Kozlov, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
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.
他の名前：
Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming. |
|
実験的：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. |
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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Core body temperature at admission to the intensive care unit
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perioperative axillary temperature
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Postoperative day 1
|
Base excess determined by venous blood gas analysis. Measured in millimoles per litre. |
Postoperative day 1
|
|
Plasma lactate concentration
時間枠：Postoperative day 1
|
Lactate concentration determined in venous blood. Measured in millimoles per litre. |
Postoperative day 1
|
|
Serum C-reactive protein concentration
時間枠：Postoperative day 1
|
C-reactive protein concentration determined in venous blood. Measured in milligrams per litre. |
Postoperative day 1
|
|
Total SOFA score
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of screened participants who were randomised
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Valentin S Kozlov, MD、The Leningrad Regional Clinical Hospital
- 主任研究者：Ionas S Simutis, MD, Dsc、North-Western State Medical University named after I.I.Mechnikov
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LOKB-TTM-2024-01
- Protocol N. 9 dated 23.10.2024 (その他の識別子：Local Ethics Committee, North-Western State Medical University named after I.I. Mechnikov)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Beginning 6 months after publication of the main results and ending 3 years thereafter.
IPD 共有アクセス基準
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.
試験データ・資料
-
研究プロトコル
情報識別子：OSF.IO/4GCFX情報コメント：
Study protocol summary, version 1.0
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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