Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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 Trendelen

Первичные конечные точки

• ΔEELV between baseline and after extubation before leaving the operating room. [Срок оценки: 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).]

Вторичные конечные точки (12)

• Proportion of patients with postoperative pulmonary complications at day 7 [Срок оценки: This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery]
• Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram [Срок оценки: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
• Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram [Срок оценки: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
• Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram [Срок оценки: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
• Recruitment rate [Срок оценки: Day 0]
• Intervention deliverability [Срок оценки: From intubation to extubation at Day 0]
• EELV [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Beth Israel Deaconess Medical Center — Boston

Публикации

• Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13. PMID 29793604
• Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186/1471-2253-14-51. eCollection 2014. PMID 25018668

Идентификаторы

NCT: NCT07277244 · 2025P000986

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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