小児外科患者の体液状態を評価するためのツールとしてのバイオ インピーダンス モニタリング? (PedFluid研究)
小児外科患者の体液状態を評価するためのツールとしてのバイオ インピーダンス モニタリング: 体液変化を測定できますか
The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.
調査の概要
状態
条件
詳細な説明
The Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is the first device that determines individual fluid status and body composition in an easy and objective way. The technology uses bioimpedance spectroscopy (BIS) to determine total body water (TBW) and extracellular water volume (ECW).It measures at 50 frequencies over a range from 5 to 1000 kHz to determine the electrical resistances of the total body water and the extracellular water. While high-frequency current passes through the total body water, low-frequency current cannot penetrate cell membranes and thus flows exclusively through the extracellular water.
To obtain the clinically relevant output parameters, two advanced physiological models are used in the BCM: a volume model, describing electrical conductance in a cell suspension enabling the total body water and extracellular water as well as the intracellular water (ICW) to be calculated, and a body composition model calculating the three principal body compartments overhydration, lean tissue and adipose tissue from ECW and TBW information.
The measurement is a non-invasive and accurate method that is easy to apply and results are obtained within just two minutes. It has been extensively used in patients with kidney disease receiving dialysis, both in adult and pediatric patients. However, bio impedance spectrometry has not yet been tested in the perioperative setting.
This is a single-center pilot study to evaluate if bio impedance measurement is a workable tool to determine fluid shifts in the pediatric population after a surgical procedure was performed under general anesthesia. Patients will be seen preoperatively by an anesthesiologist which is standard of care upon surgery under general anesthesia and eligibility will be evaluated. Informed consent will be asked and has to be signed by the accompanying parent or legal guardian. Where possible, care will be taken to inform the child itself about the content of the study and to get a written acknowledge. There are no other investigations necessary for this research. All patients on the day of surgery will be fasted as by the guidelines of the European Society of Anesthesia. For patients in daycare surgery, measurements with BCM will be performed preoperatively and postoperatively before ending the IV line on the ward. For inpatient hospitalisation, measurements by BCM will be performed preoperatively, postoperatively 6 hours after induction and postoperatively 24 h after induction.. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again and only good quality measurements will be used.
Data are collected on chip cards by the BCM. Data can be transferred to a personal computer for further analysis with the Fluid Management Tool (FMT). Site requirements is the availability of a low electronic surrounding for correct measurement. After discharge of the hospital no further follow up assessments regarding this study are needed.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Antwerp
-
Edegem、Antwerp、ベルギー、2650
- Antwerp University Hospital
-
-
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:
- Scheduled for elective surgery or investigation under general anesthesia
- Day care or inpatient hospitalisation
Exclusion Criteria:
- If sedation is needed instead of general anesthesia
- Critically ill patients for urgent surgery
- Patients who cannot lie still for performing correct measurements on the bio impedance monitor
- No informed consent obtained
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:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
他の:Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia
All subjects receive bio impedance monitor measurements pre operatively and post operatively. |
The Body Composition Monitor provides information about the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. Four electrodes are used per measurement. All subjects get electrodes attached, following the wrist-ankle approach, in a tetrapolar arrangement. Two electrodes are placed on the hand: one on the wrist, and the second on the dorsal side of the metacarpalia, close to the phalanges. The other two electrodes are placed on the foot: one on the ankle, and the second on the dorsal side of the metatarsals, close to the phalanges of the toes. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again. Measurements are taken under supervision of a trained technician or nurse. |
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 |
|---|---|---|
|
total body water
時間枠:measurements with BCM will be done pre-surgery
|
sum of intracellular water and extracellular water, calculated in liter |
measurements with BCM will be done pre-surgery
|
|
total body water
時間枠:measurements with BCM will be done within 6 hours post-surgery for patients in day care
|
sum of intracellular water and extracellular water, calculated in liter |
measurements with BCM will be done within 6 hours post-surgery for patients in day care
|
|
total body water
時間枠:measurements with BCM will be done within 24 hours post-surgery for hospitalized patients
|
sum of intracellular water and extracellular water, calculated in liter |
measurements with BCM will be done within 24 hours post-surgery for hospitalized patients
|
協力者と研究者
捜査官
- 主任研究者:Vera Saldien, MD,PhD、University Hospital, Antwerp
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2021-0576
- 002090 (その他の識別子:Edge)
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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