Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

Официальное название

Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.

Обзор

The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Подробное описание

Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Вмешательства

• Процедура Early postoperative day 0 (POD 0) chest tube removal.
  Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If air
• Процедура Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
  Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Первичные конечные точки

• 1. Pneumothorax requiring chest tube reinsertion [Срок оценки: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)]
• 2. Pleural effusion requiring thoracocentesis [Срок оценки: Pleural effusion 2 hours after chest tube removal between POD 0 and 30]
• 3. Prolonged air leak > 5 days [Срок оценки: Chest tube removal between POD 6 and 30]
• 4. Re-admission or reoperation due to pleural complication [Срок оценки: Up to 1 month after first operation]

Вторичные конечные точки (4)

• 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) [Срок оценки: Up to 1 month after initial operation]
• 2. Re-operation [Срок оценки: Up to 1 month after initial operation]
• 3. Length of drainage (days) [Срок оценки: Up to 1 month after initial operation]
• 4. Length of stay (days) [Срок оценки: Up to 1 month after initial operation]

Критерии участия

Критерии включения

• Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
• Thoracoscopic pleural biopsy
• Signed consent
• Age of majority

Критерии исключения

• Anatomical resection
• Empyema
• Pleural effusion
• Pleurodesis
• Vulnerable persons (Pregnant women, Children and adolescents)

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital of Bern, Inselspital — Bern

Идентификаторы

NCT: NCT04670523 · EROCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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