Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery (Inprove4large)
2019年5月16日 更新者：Massimo Antonelli、Catholic University of the Sacred Heart
Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial
Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.
Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rome、イタリア、00100
- General surgery OR, A. Gemelli hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
- Obesity with body mass index>35 kg/m^2
- written informed consent
Exclusion Criteria:
- Clinical history or signs of chronic heart failure
- history of neuromuscular disease
- history of thoracic surgery
- pregnancy
- chronic respiratory failure requiring long-term oxygen administration
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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 |
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実験的：Protective ventilation
Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height [cm] -152.4)),
FiO2 0.4 and PEEP 10 cmH2O during the whole study period.
Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg.
I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period.
In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached.
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Anaesthesia induction will be obtained with i.v.
2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium.
Anaesthesia will be maintained with i.v.
propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h.
Treatment of eventual hemodynamic instability will be left to the attending physician
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
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アクティブコンパレータ：Standard Ventilation
Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height [cm] -152.4)),
FiO2 0.4 and PEEP 5 cmH2O during the whole study period.
Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg.
I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second
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Anaesthesia induction will be obtained with i.v.
2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium.
Anaesthesia will be maintained with i.v.
propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h.
Treatment of eventual hemodynamic instability will be left to the attending physician
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
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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 oxygenation
時間枠：One hour after extubation
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PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%
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One hour after extubation
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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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Postoperative forced expiratory volume in 1 second (FEV1)
時間枠：48 hours after the end of surgery
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volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity
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48 hours after the end of surgery
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Postoperative forced vital capacity (FVC)
時間枠：48 hours after the end of surgery
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the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity
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48 hours after the end of surgery
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Postoperative Tiffeneau index
時間枠：48 hours after the end of surgery
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computed as FEV1/FVC
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48 hours after the end of surgery
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Postoperative Dyspnea
時間枠：1 hour after surgery
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Dyspnea assessed by Borg dyspnea scale
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1 hour after surgery
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Pulmonary infection
時間枠：24 hours after the end of surgery
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modified clinical pulmonary infection score (mCPIS)
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24 hours after the end of surgery
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Postoperative pulmonary infiltrates
時間枠：24 hours after the end of surgery
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Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment
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24 hours after the end of surgery
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Intraoperative driving pressure
時間枠：during surgery, recorded on a 60-minute basis
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driving pressure, computed as Plateau pressure-PEEP
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during surgery, recorded on a 60-minute basis
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Intraoperative lung driving pressure
時間枠：during surgery, recorded on a 60-minute basis
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transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative oxygenation
時間枠：during surgery, recorded on a 60-minute basis
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PaO2/FiO2
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during surgery, recorded on a 60-minute basis
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Intraoperative dead space
時間枠：during surgery, recorded on a 60-minute basis
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Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
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during surgery, recorded on a 60-minute basis
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Lung recruitment
時間枠：during surgery, recorded on a 60-minute basis
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lung recruitment/changes in end expiratory lung volume between the two groups
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during surgery, recorded on a 60-minute basis
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Intraoperative blood pressure
時間枠：during surgery, recorded on a 60-minute basis
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Arterial blood pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative respiratory system compliance
時間枠：during surgery, recorded on a 60-minute basis
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computed as Tidal volume/airway driving pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative lung compliance
時間枠：during surgery, recorded on a 60-minute basis
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computed as Tidal volume/lung driving pressure
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during surgery, recorded on a 60-minute basis
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年5月1日
一次修了 (実際)
2019年3月31日
研究の完了 (実際)
2019年3月31日
試験登録日
最初に提出
2017年5月12日
QC基準を満たした最初の提出物
2017年5月15日
最初の投稿 (実際)
2017年5月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月20日
QC基準を満たした最後の更新が送信されました
2019年5月16日
最終確認日
2019年5月1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。
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