Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

Официальное название

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial

Обзор

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Вмешательства

• Процедура Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
  The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial

Первичные конечные точки

• Proportion of participants developing one or more postoperative pulmonary complications (PPCs) [Срок оценки: The first 5 postoperative days]

Вторичные конечные точки (9)

• Intraoperative complications [Срок оценки: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours]
• Intraoperative fluid strategy [Срок оценки: During general anesthesia]
• Impaired wound healing [Срок оценки: The first 5 postoperative days]
• Postoperative extrapulmonary complications [Срок оценки: The first 5 postoperative days]
• Mortality [Срок оценки: Postoperative day 5, day 30 and day 90]
• Length of stay [Срок оценки: Postoperatively until the end of the 90 day follow-up period]
• Oxygen use [Срок оценки: The first 5 postoperative days]
• Antibiotics use [Срок оценки: The first 5 postoperative days]
• Thoracic imaging [Срок оценки: The first 5 postoperative days]

Критерии участия

Критерии включения

• age > 18 years; AND
• scheduled for minimally invasive abdominal surgery; AND
• at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
• signed written informed consent

Критерии исключения

• planned for open abdominal surgery;
• planned for surgery in lateral or prone position;
• planned for combined abdominal and intra-thoracic surgery
• confirmed pregnancy;
• consent for another interventional trial during anesthesia;
• having received invasive ventilation > 30 minutes within the last five days;
• any previous lung surgery;
• history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
• history of acute respiratory distress syndrome (ARDS);
• expected to require postoperative ventilation;
• expected hemodynamic instability or intractable shock;
• severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam University Medical Center — Amsterdam

Публикации

• GENERATOR-investigators. Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial. Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x. PMID 39456048

Идентификаторы

NCT: NCT06101511 · NL82971.018.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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