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Brief Bronchial Suction for Lung Collapse During Uniportal VATS

16. června 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Bronchial suction
Participants will receive bronchial suction through the operative lumen of the double-lumen endotracheal tube
Jiný: 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.
Žádný zásah: No bronchial suction
Participants will undergo one-lung ventilation without bronchial suction

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of lung collapse at 1 minute after pleural opening
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Mahidol University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Nattaya Raykateeraroj, MD, Siriraj Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. července 2028

Dokončení studie (Odhadovaný)

1. července 2028

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

16. června 2026

První zveřejněno (Aktuální)

22. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SIRIRAJ-SUCTION-UVATS-2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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