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手術室における低強度機械的換気：パイロット研究 (VIOLET)

2026年10月5日 更新者：Maximilian S Schaefer、Beth Israel Deaconess Medical Center

手術室における低強度人工呼吸管理：パイロット研究

The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.

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

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Beth Israel Deaconess Medical Center

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

全て

説明

Inclusion Criteria:

  • Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure

Exclusion Criteria:

  • Known pregnancy
  • Pre-existing intubation or tracheostomy
  • Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery
  • Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)

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：独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Control

A guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis.
実験的：Intervention

A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings.
デバイス：Low Intensity Mechanical Ventilation

A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure:

  1. Recruitment maneuver
  2. Tidal volume set to 8 ml/kg predicted body weight (PBW) and stepwise adjustment to achieve a driving pressure (Plateau pressure - PEEP) < 13 cmH2O with a minimum tidal volume of 5ml/kg PBW
  3. Respiratory rate adjustment to maintain a target end-tidal carbon dioxide concentration (etCO₂) between 45 and 55 mmHg.
  4. Reassessment and adaptation after Trendelenburg positioning and pneumoperitoneum.
  5. Re-adjustment of Tidal Volume and PEEP ventilator settings to (2.) after exsufflation and return to the supine position. FiO₂ set to 70% during the washout phase of the inhalational anesthetic until extubation.

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
ΔEELV between baseline and after extubation before leaving the operating room.
時間枠：Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).

Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room.
Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients with postoperative pulmonary complications at day 7
時間枠：This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery

Re-intubation, hypoxemia requiring oxygen therapy, pleural effusion, pneumonia, atelectasis or emergency non-invasive ventilation
This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery
Recruitment rate
時間枠：Day 0

Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached.
Day 0
Intervention deliverability
時間枠：From intubation to extubation at Day 0

proportion of patients in the intervention arm in whom the full bundle of protective low-intensity ventilation strategies is delivered as planned across all predefined intraoperative phases.
From intubation to extubation at Day 0
EELV
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

End-expiratory lung volume measured by Electrical Impedance Tomography in mL
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission
COV
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

Center of ventilation measured by Electrical Impedance Tomography in percentage
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission
RVDI
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

Regional ventilation delay inhomogeneity measured by Electrical Impedance Tomography (unitless)
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission
GI
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

Global inhomogeneity index measured by Electrical Impedance Tomography (unitless)
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission
Dorsal ROI
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

Maximum dorsal ratio of impedance measured by Electrical Impedance Tomography (unitless)
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission
EEPL
時間枠：Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation

End-expiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)
Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation
EIPL
時間枠：Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation

End-inspiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)
Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation
Relationship between body mass index with optimal PEEP
時間枠：Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

Correlation between BMI (kg/m²) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.
Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery
Relationship of the degree of Trendelenburg inclination with optimal PEEP
時間枠：Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

Correlation between the degree of Trendelenburg inclination (in degree) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.
Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery
Relationship of the pneumoperitoneum (insufflation) with optimal PEEP
時間枠：Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

Correlation between the pneumoperitoneum (insufflation in cmH2O) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.
Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery
Intraoperative oxygenation
時間枠：Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation

Intraoperative peripheral pulsed oxygen saturation (SpO2)
Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation
Postoperative oxygenation
時間枠：Postoperative Day 0: after PACU admission and 60min after PACU admission

Postoperative peripheral pulsed oxygen saturation (SpO2)
Postoperative Day 0: after PACU admission and 60min after PACU admission

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。

スポンサー

Beth Israel Deaconess Medical Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2026年4月8日

一次修了 (実際)

2026年9月16日

研究の完了 (実際)

2026年9月23日

試験登録日

最初に提出

2025年11月20日

QC基準を満たした最初の提出物

2025年12月2日

最初の投稿 (実際)

2025年12月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月5日

最終確認日

2026年10月1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

  • 2025P000986

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?

未定

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

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

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