一回換気量チャレンジと肺リクルートメント操作 (TIDALREC): 体液反応性に対する脈圧変動または一回拍出量変動の信頼性。 (TIDALEC)
術中の血行動態の最適化: 脈圧の変化と収縮期駆出量の変化を監視することによる、一回換気量チャレンジと肺リクルートメント操作の流体応答性に対する予測値。
In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).
The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.
調査の概要
状態
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
-
-
-
Lille、フランス、59037
- Hop Claude Huriez Chu Lille
-
-
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:
- Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
- Block duration > 2 hours.
Exclusion Criteria:
- open thoracique surgery
- history of supra ventricular arrhythmias
- beta-blocking patient
- BMI>30 kg.m-2 or <15 kg.min-2
- right ventricular dysfunction
- severe valvulopathies
- intracardiac shunt
- renal failure dialysis
- patient's refusal
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：ふるい分け
- 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 |
|---|---|
|
実験的：Group 1
Starting LRM (Lung Recruitment Maneuver) |
The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times). |
|
実験的：Group 2
Starting VtC (Tidal Volume Challenge) |
The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times). |
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 |
時間枠 |
|---|---|
|
一回換気量チャレンジ (VtC) 中の脈圧 (VPP) の変動の ROC 曲線 (AUC) の下の領域。
時間枠：手術中 (平均長さは 3 から 5 時間の間で予想される)。手術中に数回発生する可能性のある 30 分間のシーケンス中に実行される測定
|
手術中 (平均長さは 3 から 5 時間の間で予想される)。手術中に数回発生する可能性のある 30 分間のシーケンス中に実行される測定
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.
時間枠：throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The AUCs of the two techniques calculated above.
時間枠：throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).
時間枠：throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.
時間枠：throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
Number of complications in pneumothorax
時間枠：1 day (at recovery room after surgery) and at day 2
|
Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2. |
1 day (at recovery room after surgery) and at day 2
|
協力者と研究者
捜査官
- 主任研究者：Gilles Lebuffe, MD,PhD、University Hospital, Lille
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
その他の研究ID番号
- 2019_71
- 2020-A01460-39 (その他の識別子：ID-RCB number,ANSM)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。