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Brief Bronchial Suction for Lung Collapse During Uniportal VATS

16 июня 2026 г. обновлено: Mahidol University

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

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

Обзор исследования

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

100

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Nattaya Raykateeraroj, MD
  • Номер телефона: +66993519963
  • Электронная почта: raykageeraroj@gmail.com

Учебное резервное копирование контактов

Места учебы

      • Bangkok, Таиланд, 10700
        • Siriraj Hospital, Mahidol University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Bronchial suction
Participants will receive bronchial suction through the operative lumen of the double-lumen endotracheal tube
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.
Без вмешательства: No bronchial suction
Participants will undergo one-lung ventilation without bronchial suction

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Quality of lung collapse at 1 minute after pleural opening
Временное ограничение: At 1 minute after pleural opening
Surgical team to assess quality of lung collapse at 1 minute after pleural opening by using lung collapse score (LCS). The higher the LCS, the better the lung collapse.
At 1 minute after pleural opening

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening
Временное ограничение: At pleural opening, and at 5 and 10 minutes after pleural opening
Quality of lung collapse assessed by the surgical team using the Lung Collapse Score (LCS) immediately after pleural opening, and at 5 minutes and 10 minutes after pleural opening.
At pleural opening, and at 5 and 10 minutes after pleural opening
Time to satisfactory lung collapse
Временное ограничение: From pleural opening until the first LCS of 8 or greater, assessed up to 10 minutes after pleural opening
Time from pleural opening to the first Lung Collapse Score (LCS) of 8 or greater
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
Временное ограничение: From pleural opening until the end of one-lung ventilation during the index surgery up to 6 hours
Need for additional intraoperative maneuvers to improve lung collapse due to inadequate surgical exposure
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
Временное ограничение: At baseline after induction of anesthesia and at 30-60 minutes after completion of one-lung ventilation
Plasma interleukin-6 level measured at baseline after induction of anesthesia and 30-60 minutes after completion of one-lung ventilation in the post-anesthesia care unit.
At baseline after induction of anesthesia and at 30-60 minutes after completion of one-lung ventilation
Incidence of intraoperative hypoxemia
Временное ограничение: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index surgery up to 6 hours
Occurrence of intraoperative hypoxemia during one-lung ventilation, defined as SpO2 < 90%
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
Временное ограничение: From end of surgery through postoperative day 7 or hospital discharge, whichever occurs first
Occurrence of postoperative pulmonary complications within 7 days after surgery or until hospital discharge, whichever occurs first. These include, but are not limited to, atelectasis, pneumonia, pulmonary aspiration, respiratory infection, pleural effusion, pneumothorax, bronchospasm, pulmonary edema, and respiratory failure.
From end of surgery through postoperative day 7 or hospital discharge, whichever occurs first
Total operative duration
Временное ограничение: From surgical incision to completion of surgery during the index operation, up to 6 hours
Duration of surgery measured from surgical incision to completion of surgery.
From surgical incision to completion of surgery during the index operation, up to 6 hours
Duration of one-lung ventilation
Временное ограничение: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index operation, up to 6 hours
Total duration of one-lung ventilation during surgery
From initiation of one-lung ventilation until resumption of two-lung ventilation during the index operation, up to 6 hours

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Nattaya Raykateeraroj, MD, Siriraj Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 августа 2026 г.

Первичное завершение (Оцененный)

1 июля 2028 г.

Завершение исследования (Оцененный)

1 июля 2028 г.

Даты регистрации исследования

Первый отправленный

8 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

16 июня 2026 г.

Первый опубликованный (Действительный)

22 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • SIRIRAJ-SUCTION-UVATS-2026

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

There is no current plan to share individual participant data outside the study team

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования bronchial suction

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