Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Brief Bronchial Suction for Lung Collapse During Uniportal VATS

16 de junio de 2026 actualizado 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

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Nattaya Raykateeraroj, MD
  • Número de teléfono: +66993519963
  • Correo electrónico: raykageeraroj@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Sin intervención: No bronchial suction
Participants will undergo one-lung ventilation without bronchial suction

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of lung collapse at 1 minute after pleural opening
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Nattaya Raykateeraroj, MD, Siriraj Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SIRIRAJ-SUCTION-UVATS-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre bronchial suction

Suscribir