Double Lumen Tube Intubation, One-Lung Ventilation, Thoracoscopic Surgery
Conditions
Keywords
Video-guided right-sided double-lumen tube, Right-sided double-lumen tube, One-lung ventilation, Fibreoptic bronchoscopy, Thoracoscopic surgery, Lung isolation
Brief summary
This multicentre randomised controlled trial compares a video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adults undergoing elective thoracoscopic surgery requiring one-lung ventilation. The video-guided tube incorporates an integrated camera that provides continuous airway visualisation during initial placement and intraoperative monitoring. Participants will be randomly assigned in a 1:1 ratio to receive one of the two tubes. Final tube position after initial placement will be confirmed by fibreoptic bronchoscopy in both groups. During one-lung ventilation, additional fibreoptic bronchoscopy will be performed only when clinically indicated or according to predefined rescue criteria. The primary outcome is successful initial right-sided double-lumen tube placement. Secondary outcomes include right upper-lobe bronchial obstruction, intraoperative tube displacement, hypoxemia during one-lung ventilation, requirement for rescue fibreoptic bronchoscopy, time to satisfactory tube positioning, quality of operative lung collapse, and the number of intraoperative tube repositioning events. Participants and outcome assessors will remain blinded to treatment allocation, whereas the anaesthesiologist performing intubation cannot be blinded because of the distinct visual and operational characteristics of the two devices. The study aims to determine whether continuous airway visualisation improves the effectiveness and stability of right-sided double-lumen tube management during thoracoscopic surgery.
Detailed description
Right-sided double-lumen tubes are used to achieve lung isolation and one-lung ventilation during thoracoscopic surgery. Accurate positioning is particularly important because of the short right main bronchus and the need to maintain patency of the right upper-lobe bronchial opening. Malposition or displacement of a right-sided double-lumen tube may impair right upper-lobe ventilation, compromise lung isolation, and require repeated tube repositioning or fibreoptic bronchoscopy. This prospective, multicentre, parallel-group randomised controlled trial will enrol 566 adult participants undergoing elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. Participants will be randomly allocated in a 1:1 ratio to either a video-guided right-sided double-lumen tube or a conventional right-sided double-lumen tube. In the video-guided group, an integrated visualisation system provides continuous airway visual feedback during initial tube positioning and intraoperative monitoring, allowing real-time identification of changes in tube position. In the conventional group, initial tube placement is performed using standard clinical techniques and anatomical landmarks. After initial positioning, final tube position will be confirmed by fibreoptic bronchoscopy in both groups. Subsequent fibreoptic bronchoscopy during one-lung ventilation will be performed only when clinically indicated or according to predefined rescue criteria. The primary outcome is successful initial right-sided double-lumen tube placement, defined as placement of the assigned tube on the first intubation attempt with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation. Secondary outcomes include the incidence of right upper-lobe bronchial obstruction confirmed by fibreoptic bronchoscopy; incidence of intraoperative double-lumen tube displacement; incidence of hypoxemia during one-lung ventilation; requirement for rescue fibreoptic bronchoscopy; time to satisfactory right-sided double-lumen tube positioning; quality of operative lung collapse assessed by the operating surgeon; and the number of intraoperative tube repositioning events. Participants and outcome assessors will remain blinded to treatment allocation. Because the video-guided and conventional right-sided double-lumen tubes have distinct visual and operational characteristics, the anaesthesiologist performing tracheal intubation and other intraoperative personnel directly involved in airway management cannot be blinded. Outcome assessment will be performed by personnel who are not involved in the airway intervention and remain unaware of treatment allocation. The trial is designed to determine whether continuous airway visualisation improves initial placement success, maintains more stable right-sided double-lumen tube positioning, reduces the need for subsequent airway interventions, and improves clinically relevant conditions during one-lung ventilation.
Interventions
DEVICEVideo-guided right-sided double-lumen tube
A right-sided double-lumen tube with an integrated visualisation system that provides continuous airway visual feedback during placement and intraoperative monitoring. Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
DEVICEConventional right-sided double-lumen tube
A conventional right-sided double-lumen tube used for lung isolation. Initial placement is performed using standard clinical techniques and anatomical landmarks. Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
Sponsors
Diansan Su
First Affiliated Hospital of Zhejiang University
The Second Affiliated Hospital of Jiaxing University
Affiliated Hospital of Jiaxing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will remain blinded to treatment allocation. Because the video-guided and conventional right-sided double-lumen tubes have distinct visual and operational characteristics, the anaesthesiologist performing tracheal intubation and other intraoperative personnel directly involved in airway management cannot be blinded to group assignment. Outcome assessment will be performed by personnel who are not involved in the airway intervention and remain unaware of treatment allocation. Treatment allocation will not be disclosed to participants or blinded outcome assessors unless clinically necessary.
Intervention model description
Multicentre, randomized, parallel-group controlled trial with 1:1 allocation to video-guided right-sided double-lumen tube placement or conventional right-sided double-lumen tube placement.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*Inclusion Criteria:\*\* 1. Adults aged 18 years or older. 2. American Society of Anesthesiologists physical status I-III. 3. Scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. 4. Able to provide written informed consent. \*\*
Exclusion criteria
\*\* 1. Contraindication to placement of a right-sided double-lumen tube, including a lesion involving the right main bronchus that precludes its use. 2. Known tracheobronchial anatomical abnormality that may interfere with right-sided double-lumen tube placement or lung isolation. 3. Known or anticipated difficult airway. 4. Requirement for rapid-sequence induction. 5. Emergency surgery. 6. Severe respiratory instability that, in the investigator's judgement, makes participation unsafe. 7. Concurrent participation in another interventional clinical trial that could interfere with the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful initial right-sided double-lumen tube placement | From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes). | Successful initial placement is defined as placement of the assigned right-sided double-lumen tube on the first intubation attempt, with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of right upper-lobe bronchial obstruction | After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes). | Right upper-lobe bronchial obstruction is defined as partial or complete obstruction of the right upper-lobe bronchial opening by the bronchial lumen or bronchial cuff after initial tube positioning, as confirmed by fibreoptic bronchoscopy. The outcome will be recorded as present or absent. |
| Incidence of intraoperative double-lumen tube displacement | From initiation of one-lung ventilation until completion of one-lung ventilation. | Tube displacement is defined as any intraoperative displacement of the double-lumen tube that requires repositioning to restore satisfactory tube position, ventilation, or lung isolation. The outcome will be recorded as present or absent. |
| Incidence of hypoxemia during one-lung ventilation | During one-lung ventilation. | Hypoxemia is defined as peripheral oxygen saturation (SpO₂) \<90% during one-lung ventilation. The outcome will be recorded as present or absent. |
| Requirement for rescue fibreoptic bronchoscopy | From completion of initial tube positioning until completion of one-lung ventilation. | Rescue fibreoptic bronchoscopy is defined as fibreoptic bronchoscopy performed after initial tube positioning because of suspected tube malposition, inadequate lung isolation, ventilation abnormality, or need for tube repositioning. The outcome will be recorded as present or absent. |
| Time to satisfactory right-sided double-lumen tube positioning | During initial tube placement after anaesthesia induction (approximately 10 minutes). | Time from removal of the stylet after the bronchial cuff passes the vocal cords to confirmation of satisfactory right-sided double-lumen tube position. The duration will be recorded in seconds. |
| Quality of operative lung collapse | 20 minutes after initiation of one-lung ventilation. | The operating surgeon, blinded to treatment allocation, will assess operative lung collapse using a three-category scale: excellent (complete collapse with optimal surgical exposure), good (minor residual inflation without interference with surgery), or poor (incomplete collapse interfering with surgical exposure). |
| Number of intraoperative double-lumen tube repositioning events | From initiation of one-lung ventilation until completion of one-lung ventilation. | The number of separate tube repositioning procedures required after satisfactory initial placement will be recorded for each participant. |
Countries
China
Contacts
CONTACTHeng Wen
Outcome results
None listed