Effectiveness of Dextrose Pleurodesis for the Management of Post-Operative Air Leak
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: 50% Dextrose Pleurodesis, Standard of Care Chest Drainage.
- Кому может быть актуально
- Состояния в реестре: Post Operative Pulmonary Air Leak. 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Dextrose Pleurodesis Versus Standard of Care for the Management of Post-Operative Air Leak: A Single Center Prospective Trial
Обзор
A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. For most patient, an air leak will self-resolve by maintaining a drainage catheter in the chest for a prolonged period. However, for some patients, additional measures are required to help seal the affected tissue. Known strategies for managing post-operative air leak include placing one-way valves, surgical revision, and chemical pleurodesis. Chemical pleurodesis involves injecting an irritant through the chest drainage catheter to promote sealing of the leaking lung tissue. While many agents exist for chemical pleurodesis, a relatively new method for treating an air leak is by using dextrose solution. Dextrose is appealing due to low cost and availability. Dextrose solution has shown some efficacy in other countries and undergone Phase 1 clinical investigation in Canada to show its safety and dosing recommendations. In this study, our aim is to compare the effectiveness of using dextrose solution for treating post-operative air leak compared to usual care with chest tube drainage alone.
Вмешательства
- Препарат 50% Dextrose Pleurodesis
A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine - Другое Standard of Care Chest Drainage
maintenance of post operative pulmonary drain without additional intervention
Первичные конечные точки
- Time to air leak resolution [Срок оценки: from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days]
Вторичные конечные точки (3)
- Chest tube duration [Срок оценки: from randomization until chest tube removal, assessed up to 30 days]
- Hospital Length of Stay [Срок оценки: from randomization until hospital discharge, assessed up to 30 days]
- Adverse Events [Срок оценки: from randomization through 30 days post-procedure]
Критерии участия
Критерии включения
- Adult patients who have undergone lung resection
- Persistent post-operative air leak >24 hours after surgery with air leak >20 mL/min
Критерии исключения
- pregnant patients
- incarcerated patients
- patients with early post-operative complications
- hemodynamic instability
- need for mechanical ventilator support
- high volume chest tube output (>750 mL over 24h)
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Qiabi, Mehdi. "PLeurodesis Using hypertonic Glucose administration to treat post-operative air leaks following lung resection surgery (PLUG): Phase I trial." (2021).
- Tsukioka T, Inoue K, Oka H, Mizuguchi S, Morita R, Nishiyama N. Pleurodesis with a 50% glucose solution in patients with spontaneous pneumothorax in whom an operation is contraindicated. Ann Thorac Cardiovasc Surg. 2013;19(5):358-63. doi: 10.5761/atcs.oa.12.01986. Epub 2012 Dec 26. PMID 23269268
- Fujino K, Motooka Y, Koga T, Osumi H, Matsubara E, Shibata H, Ikeda K, Shiraishi K, Mori T, Hayashi K, Yoshimoto K, Wakimoto J, Kubota I, Suzuki M. Novel approach to pleurodesis with 50 % glucose for air leakage after lung resection or pneumothorax. Surg Today. 2016 May;46(5):599-602. doi: 10.1007/s00595-015-1223-2. Epub 2015 Jul 24. PMID 26206407
- Hong JI, Lee JH, Kim HK. Early Pleurodesis for Postoperative Air Leak with Autologous Blood and 50% Glucose Solution. J Chest Surg. 2023 Jan 5;56(1):16-22. doi: 10.5090/jcs.22.096. Epub 2022 Dec 19. PMID 36530129
- Mueller MR, Marzluf BA. The anticipation and management of air leaks and residual spaces post lung resection. J Thorac Dis. 2014 Mar;6(3):271-84. doi: 10.3978/j.issn.2072-1439.2013.11.29. PMID 24624291
- Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263. PMID 11083673
- Elsayed H, McShane J, Shackcloth M. Air leaks following pulmonary resection for lung cancer: is it a patient or surgeon related problem? Ann R Coll Surg Engl. 2012 Sep;94(6):422-7. doi: 10.1308/003588412X13171221592258. PMID 22943333
- Dugan KC, Laxmanan B, Murgu S, Hogarth DK. Management of Persistent Air Leaks. Chest. 2017 Aug;152(2):417-423. doi: 10.1016/j.chest.2017.02.020. Epub 2017 Mar 4. PMID 28267436
Идентификаторы
NCT: NCT07548047 · TJUH-iRISID-2025-0028