The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation (ERAS)
The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS (Enhanced Recovery After Surgery) Strategy: a Prospective Investigation
調査の概要
詳細な説明
ERAS (Enhanced recovery after surgery) strategy is extremely important for patients receiving esophagectomy including the preoperative preparation (smoking cessation, exercise prescription and nutrition prescription), intraoperative management, and postoperative analgesia and respiratory rehabilitation. However, despite the less invasive thoracoscopic esophagectomy and laparoscopic gastric tube reconstruction was developed, respiratory complications including acute lung injury (ALI) were observed up to 20% and associate with 50% of mortality. A new preventive anesthetic ERAS strategy including precise perioperative fluid management and preventive management after tracheal extubation should be developed.
Previous report indicated that none of the variables studied except fluid administration were shown as a risk factor for the development of respiratory complications on the multivariate analysis on esophageal surgery. However, there are rare prospective investigations of perioperative fluid administration strategy on postoperative complications after esophagectomy. Our group has studied on goal-directed fluid optimization and we found that the goal of optimization may differ for specific surgery. For esophagectomy, new anesthetic ERAS strategy should include precise preoptimized circulatory management and aggressive postoperative pulmonary care. Based on Frank-Starling law (stroke volume, SV, response to fluid therapy), a precise goal for perioperative goal-directed fluid therapy (GDFT) becomes possible in anesthetic practice. However, the effects of preoperative maximization of SV remain unknown. Following our study in last year, we planned to randomize 120 esophagectomy patients in the following 3 years into different GDFT groups (SV maximization and SV normalization groups). Postoperative THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) therapy will be take place immediately after tracheal extubation. Blood samples will be obtained preoperatively to postoperative day 1 to measure lung injuries, kidney injuries as well as the inflammatory and oxidative markers. The clinical records will be collected (including extubation time, ICU stay, hospitalization days, 30-day mortality, 90-day mortality, readmission, postoperative cardiovascular, pulmonary, and renal complications, gastric tube related complications etc. ). The goals of this study are to testify the effectiveness on enhance recovery by new anesthetic ERAS strategy.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Test2
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Taipei、Test2、台湾、100
- National Taiwan University Hospital
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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 with esophageal cancer
- Patients will undergo video-assisted thoracic surgical (VATS) esophagectomy and laparoscopic gastric tube reconstruction
Exclusion criteria:
- History of arrhythmia
- History of chronic obstructive pulmonary disease (COPD)
- With poor lung function test (FEV1 < 70% or FEV1/ forced vital capacity (FVC) < 70% of predicted)
- Preoperative creatinine more than 1.5 mg/dl
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Fluid therapy optimization
Fluid loading to optimize stroke volume after induction.
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colloid 250 mL bolus to increase stroke volume index (SVI).
If the increase of SVI is more than 10% of baseline, repeat the bolus.
If the increase of SVI is less than 10% of baseline, stop the bolus.
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介入なし:Fluid therapy normalization
No fluid loading after induction.
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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 |
|---|---|---|
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Postoperative complications
時間枠:within 1 year after operation
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Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications
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within 1 year after operation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Kidney injuries
時間枠:Preoperative to postoperative day 1
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Elevated plasma creatinine
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Preoperative to postoperative day 1
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Lung injuries
時間枠:Preoperative to postoperative day 1
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Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)
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Preoperative to postoperative day 1
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Inflammatory markers
時間枠:Preoperative to postoperative day 1
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Change in cytokines
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Preoperative to postoperative day 1
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協力者と研究者
捜査官
- 主任研究者:Ya-Jung Cheng、Anesthesiology Department, NTUH
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
食道がんの臨床試験
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Fluid therapy optimizationの臨床試験
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