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Набор скоро начнётся NCT07660588

Brief Bronchial Suction for Lung Collapse During Uniportal VATS

Без фазы С лечением Lung Collapse One-lung Ventilation Thoracic Anesthesia Thoracic Surgery, Video-assisted

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: bronchial suction.
Кому может быть актуально
Состояния в реестре: Lung Collapse, One-lung Ventilation, Thoracic Anesthesia, Thoracic Surgery, Video-assisted. 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
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Brief Bronchial Suction on the Quality of Non-Ventilated Lung Collapse and Time to Adequate Surgical Exposure During Uniportal Video-Assisted Thoracoscopic Surgery: a Randomized Patient- and Surgeon-Blinded Trial

Обзор

The goal of this clinical trial is to learn whether a brief suction of the airway going to the surgical lung (bronchus) can help the lung collapse faster and more completely during uniportal video-assisted thoracoscopic surgery (UVATS). This type of surgery is performed through a small incision in the chest, and good lung collapse helps the surgeon see and work safely. The main questions it aims to answer are 1. Does brief bronchial suction improve the quality of lung collapse 1 minute after chest cavity is opened? 2. Does brief bronchial suction help reach satisfactory lung collapse faster? Researchers will compare patients who receive brief bronchial suction and those who do not. This is to see if suction improves and fastens lung collapse, reduce the need for additional steps if lung is not adequately collapsed, affect inflammation, oxygenation, postoperative pulmonary complications, operative time, and the duration of one-lung ventilation. Participants will 1. Undergo UVATS under general anesthesia 2. Have a double-lumen breathing tube placed as part of the standard anesthetic care 3. Be randomly assigned to either receive bronchial suction for one minute or receive no bronchial suction 4. Have the surgical team assess the quality of lung collapse at different time points 5. Have blood samples taken for interleukin-6, a marker related to inflammation, once during and once after surgery. These samples are collected through a small tube in a vein that is placed as a standard anesthetic care while the participant is under general anesthesia. No extra puncture is required for blood collection. 6. Have information collected from the routine anesthesia and surgical records such as oxygen levels during surgery, length of surgery and lung-related complications within 7 days after surgery

Подробное описание

Uniportal video-assisted lung surgery (UVATS) is increasingly being performed in many centers. Due to a short interval between the skin incision and pleural opening, a rapid and adequate surgical lung collapse is important for optimal surgical exposure and operative efficiency. Delayed or inadequate lung collapse may interfere with the operative field, increase the need for manual lung manipulation by surgeons and possibly a resultant increase in lung inflammation. Brief bronchial suction through a double lumen tube has been used to facilitate lung collapse although its effectiveness is questionable in three-port VATS. This study aims to investigate if a brief bronchial suction helps achieve a better and faster lung collapse in UVATS.

Study objectives This randomized controlled trial aims to evaluate whether a brief suction through a tube in the non-ventilated lung leads to a better quality of lung collapse at one minute after the surgeon enters the chest. The study will compare the results between patients who receive a brief bronchial suction and those who do not.

Study design This is a randomized controlled trial conducted at a single university hospital in Thailand. Adult patients undergoing UVATS will be enrolled. A double-lumen endotracheal tube will be placed under general anesthesia as part of a standard anesthetic care. Patients will be randomly assigned to either receive a bronchial suction for one minute or no bronchial suction. The intervention group will undergo bronchial suction on two occasions: before pleural opening and immediately after pleural opening. Each suction period will last for 60 seconds.

The quality of lung collapse will be assessed by the surgical team at different time points during the surgery, including one minute after chest opening. Time to satisfactory lung collapse will also be evaluated.

Other perioperative data and outcome including requirement for additional steps in case of inadequate lung collapse, duration of one-lung ventilation, duration of surgery, incidence of intraoperative hypoxemia and postoperative pulmonary complications will also be collected.

To investigate the inflammatory response associated with suction and lung surgery, levels of interleukin-6 will be collected twice during and after surgery through an intravenous access placed under general anesthesia as part of a standard anesthetic care.

Potential significance The findings from this study may help to optimize anesthetic management for patients undergoing VATS, particularly UVATS, and provide evidence on the effectiveness of bronchial suction on the quality and speed of lung collapse. The information may contribute to evidence-based recommendations on intraoperative strategies to improve lung collapse during minimally invasive lung surgery.

Вмешательства

  • Другое bronchial suction
    Bronchial suction will be performed through the operative lumen of the double-lumen endobronchial tube on two occasions: before pleural opening, and immediately after pleural opening. The suction pressure is at -30 cmH2O and each suction period will last for 60 seconds.

Первичные конечные точки

  • Quality of lung collapse at 1 minute after pleural opening [Срок оценки: At 1 minute after pleural opening]
Вторичные конечные точки (8)
  • Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening [Срок оценки: At pleural opening, and at 5 and 10 minutes after pleural opening]
  • Time to satisfactory lung collapse [Срок оценки: From pleural opening until the first LCS of 8 or greater, assessed up to 10 minutes after pleural opening]
  • Requirement for rescue maneuvers for inadequate lung collapse [Срок оценки: From pleural opening until the end of one-lung ventilation during the index surgery up to 6 hours]
  • Change in interleukin-6 level from baseline to after one-lung ventilation [Срок оценки: At baseline after induction of anesthesia and at 30-60 minutes after completion of one-lung ventilation]
  • Incidence of intraoperative hypoxemia [Срок оценки: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index surgery up to 6 hours]
  • Incidence of postoperative pulmonary complications [Срок оценки: From end of surgery through postoperative day 7 or hospital discharge, whichever occurs first]
  • Total operative duration [Срок оценки: From surgical incision to completion of surgery during the index operation, up to 6 hours]
  • Duration of one-lung ventilation [Срок оценки: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index operation, up to 6 hours]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • BMI ≤ 35 kg/m2
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Scheduled for elective single-port video-assisted thoracoscopic surgery (VATS) at Siriraj Hospital
  • Requirement for one-lung ventilation using a double-lumen tube (DLT)
  • Surgery performed in the lateral decubitus position
  • Ability to provide written informed consent

Критерии исключения

  • Previous thoracic surgery
  • Known or suspected severe pleural adhesions based on preoperative imaging or clinical history
  • Tracheobronchial anatomical abnormalities
  • Pulmonary bullae identified on chest radiography or computed tomography, or a history of recurrent pneumothorax
  • Forced vital capacity (FVC) < 50% of predicted
  • Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Таиланд · 1 центр
  • Siriraj Hospital, Mahidol University — Bangkok

Публикации

  • Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002. PMID 28186222
  • Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27. PMID 29661384
  • Brassard CL, Lohser J, Donati F, Bussieres JS. Step-by-step clinical management of one-lung ventilation: continuing professional development. Can J Anaesth. 2014 Dec;61(12):1103-21. doi: 10.1007/s12630-014-0246-2. Epub 2014 Nov 12. English, French. PMID 25389025
  • Reniers T, Noordzij PG, Veen EJ, Hofman EFN, Taselaar AM, Visser WA, van der Heiden P, Boeckx S, Emmen JMA, Dijkstra IM, Cremer OL, Vernooij LM, Rettig TCD. Does postoperative plasma IL-6 improve early prediction of infection after pulmonary cancer surgery? A two-centre prospective study. PLoS One. 2025 Jun 23;20(6):e0326537. doi: 10.1371/journal.pone.0326537. eCollection 2025. PMID 40549692
  • Neff TA, Braun J, Rana D, Puhan M, Filipovic M, Seeberger M, Stuber F, Neff SB, Beck-Schimmer B, Schlapfer M. Interleukin-6 Is an Early Plasma Marker of Severe Postoperative Complications in Thoracic Surgery: Exploratory Results From a Substudy of a Randomized Controlled Multicenter Trial. Anesth Analg. 2022 Jan 1;134(1):123-132. doi: 10.1213/ANE.0000000000005639. PMID 34132704
  • Fink-Neuboeck N, Lindenmann J, Bajric S, Maier A, Riedl R, Weinberg AM, Smolle-Juettner FM. Clinical impact of interleukin 6 as a predictive biomarker in the early diagnosis of postoperative systemic inflammatory response syndrome after major thoracic surgery: A prospective clinical trial. Surgery. 2016 Aug;160(2):443-53. doi: 10.1016/j.surg.2016.04.004. Epub 2016 May 17. PMID 27206334
  • Engels GE, van Oeveren W. Biomarkers of lung injury in cardiothoracic surgery. Dis Markers. 2015;2015:472360. doi: 10.1155/2015/472360. Epub 2015 Mar 17. PMID 25866435
  • Reinersman JM, Passera E, Rocco G. Overview of uniportal video-assisted thoracic surgery (VATS): past and present. Ann Cardiothorac Surg. 2016 Mar;5(2):112-7. doi: 10.21037/acs.2016.03.08. PMID 27134837

Идентификаторы

NCT: NCT07660588 · SIRIRAJ-SUCTION-UVATS-2026

Первоисточники (государственные реестры)

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