Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study
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: early chest tube removal.
- Кому может быть актуально
- Состояния в реестре: Lung Surgery, Chest Tube Removal, Enhanced Recovery After Surgery (ERAS). Базовые параметры: от 18 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.
Подробное описание
Pulmonary resections are performed for a multitude of diagnostic and therapeutic reasons. The last decade has seen a rapid advancement of minimally invasive surgical (MIS) approaches which have resulted in improved patient outcomes. However, the post-operative care pathways have not evolved sufficiently to account for these changes. As such, many patients are still admitted after a minor lung resection for monitoring with a chest tube remaining in situ for a minimum of 24 hours. There have been a few retrospective cohort studies that demonstrate that patients do not experience significant complications during that 24-hour period that would warrant hospitalization. However, there have been no prospective controlled studies evaluating the safety and feasibility of early chest tube removal and discharge after a wedge resection. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit.
Our group recently completed and presented a prospective safety and feasibility study demonstrating that chest tubes can be discontinued as early as 3 hours after minor MIS wedge resections of the lung with no adverse events. This study validated safety criteria that will be implemented moving forward. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit. In the study mentioned previously, early chest tube removal led to 40% more patients being opioid free at post operative day 1 compared to those who underwent routine care.
Nevertheless, it is unclear if patients who undergo more extensive surgeries involving vascular dissection and longer operative times (i.e., pulmonary lobectomies and segmentectomies) will derive the same benefit. The incisions required to complete more complex operations are also larger compared to wedge resections. As such the pain associated with having a chest tube may or may not be as apparent in the setting of the larger incision. It is also unclear what the long-term impact of early chest tube removal has on quality of life in the perioperative period.
Вмешательства
- Процедура early chest tube removal
Chest tube removal
Первичные конечные точки
- Rate of successful same day chest tube removal [Срок оценки: 30 days post-op]
- EuroQol 5 Dimension 5 Level (EQ5D5L) score [Срок оценки: 30 days post-op]
- Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1) [Срок оценки: 24 hours]
- Pleural reintervention [Срок оценки: 30 days post-op]
Вторичные конечные точки (4)
- Complications [Срок оценки: 30 days post-op]
- Chest Tube duration [Срок оценки: 30 days post-op]
- Unplanned return [Срок оценки: 30 days post-op]
- Length Of Stay [Срок оценки: 30 days post-op]
Критерии участия
Критерии включения
- 18 yrs or older
- scheduled to undergo elective VATS segmental or lobar resection of the lung
Критерии исключения
- Pulmonary function tests demonstrating forced expiratory volume in 1 second Forced Expiratory Volume (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide Lung Diffusion Test (DLCO) <50% predicted
- Patient receives an intraoperative pleurodesis
- Conversion to open thoracotomy or mini thoracotomy intraoperatively.
- Underlying cognitive disorder resulting in inability to complete activities of daily living.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- London Health Sciences Centre — London
Идентификаторы
NCT: NCT06444854 · PROTECTR