Набор по приглашению NCT07239557

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Ventilation

Без фазы С лечением Major Abdominal Surgery Atelectasis Lung-protective Ventilation Lung Ultrasound Score

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Different interval of PARM.
Кому может быть актуально: Состояния в реестре: Major Abdominal Surgery, Atelectasis, Lung-protective Ventilation, Lung Ultrasound Score. Базовые параметры: 65 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Mechanical Ventilation: A Randomized Biased-Coin Sequential Trial

Обзор

This study aims to determine the optimal interval for periodic alveolar recruitment maneuvers (PARM) that can achieve effective lung re-expansion in 90% of patients undergoing intraoperative mechanical ventilation during abdominal laparoscopic surgery in the low Trendelenburg position. Identifying the most effective frequency of PARM is crucial for establishing lung-protective ventilation strategies, with the ultimate goal of reducing intraoperative atelectasis, decreasing postoperative pulmonary complications, and accelerating recovery. Patients are randomized using a biased-coin sequential design. PARM is initially applied every 0.5 hours, and the effectiveness of lung re-expansion is evaluated before the end of surgery. The primary outcome is the effectiveness of recruitment, assessed by a combination of lung ultrasound scores and shunt fraction. Secondary outcomes include mechanical power at the end of surgery, time-weighted average mechanical power during ventilation, postoperative P/F ratio, dead space fraction, air test results, intraoperative adverse events, incidence of respiratory failure in the PACU and postoperative period, and postoperative length of stay. This trial is expected to provide robust evidence for defining the optimal RM interval in protective ventilation protocols for patients undergoing laparoscopic abdominal surgery, thereby contributing to improved perioperative respiratory outcomes.

Подробное описание

This study is designed to evaluate the optimal interval of periodic alveolar recruitment maneuvers (PARM) to achieve effective lung re-expansion (defined as LUS ≤1 and shunt fraction \<10%) in 90% of elderly patients undergoing laparoscopic anterior resection in low Trendelenburg position. This is a single-arm, biased-coin sequential design study. The initial PARM interval is 30 min, adjusted in 10 min increments based on response. The primary outcome is recruitment efficacy. Secondary outcomes include intraoperative mechanical power, P/F ratio, postoperative pulmonary complications, and length of hospital stay. This study aims to inform optimal RM intervals in protective ventilation protocols.

Вмешательства

Процедура Different interval of PARM
The initial time interval of PARM was 0.5 hours/time, and the different interval of PARM was assigned by random partial coin sequential method.If the previous patient did not respond to postoperative assessment of lung opening, the interval between expansion of the lungs was shortened by 10 minutes for the next patient; If lung opening is effective, there is an 11% chance that the next patient will have an 10-minute expansion interval and an 89% chance that the time interval will remain unchange

Первичные конечные точки

The effectiveness of recruitment [Срок оценки: Intraoperative]

Вторичные конечные точки (12)

Mechanical power at the end of surgery [Срок оценки: With the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver]
Time-weighted average mechanical power during surgery [Срок оценки: During intraoperative mechanical ventilation]
The P/F ratio at the end of surgery, [Срок оценки: At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)]
Dead space rate [Срок оценки: At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)]
Air-breathing test [Срок оценки: At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)]
Intraoperative hypotension [Срок оценки: During mechanical ventilation in the intraoperative period.]
Intraoperative vasopressor use. [Срок оценки: During intraoperative mechanical ventilation]
Intraoperative mild hypoxemia [Срок оценки: During intraoperative mechanical ventilation]
Intraoperative severe hypoxemia [Срок оценки: During intraoperative mechanical ventilation]
Lung ultrasound score (LUS) in the post-anesthesia care unit (PACU) [Срок оценки: Awake with spontaneous breathing before discharge from the PACU]
Rate of respiratory failure at post-anesthesia care unit (PACU) [Срок оценки: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU]
Rate of postoperative respiratory failure [Срок оценки: Day1 to 5 after surgery]

Критерии участия

Критерии включения

Age 65-80 years
Undergoing elective laparoscopic anterior resection (expected mechanical ventilation duration 2-5 hours)
Intermediate risk for postoperative pulmonary complications
Room air SpO₂ ≥94%