Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
NCT Number: NCT07660588
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Bangkok, 10700, Thailand
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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%
Time frame: 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.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Nattaya Raykateeraroj, MD
CONTACT
Rattanaporn Tankul, MD
CONTACT
Mahidol University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02919267
Lung Collapse, Lung Diseases
Québec, Canada
View Trial DetailsNCT07383129
Lung Collapse, Lung Diseases
Cairo, Egypt
View Trial DetailsNCT04235231
Consciousness Disorders, Lung Collapse
Liberec, Czechia
View Trial DetailsNCT06909630
Lung Collapse, Lung Diseases
Seongnam-si, Gyeonggi-do, South Korea
View Trial Details