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Brief Bronchial Suction for Lung Collapse During Uniportal VATS

16 de junho de 2026 atualizado por: 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

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Sem intervenção: No bronchial suction
Participants will undergo one-lung ventilation without bronchial suction

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Quality of lung collapse at 1 minute after pleural opening
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Nattaya Raykateeraroj, MD, Siriraj Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de julho de 2028

Conclusão do estudo (Estimado)

1 de julho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • SIRIRAJ-SUCTION-UVATS-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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