One-lung Ventilation, Thoracic Surgery
Conditions
Keywords
Double-lumen tube, Thoracic anesthesia, CT-guided intubation, One-lung ventilation
Brief summary
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation
Detailed description
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation. The study aims to evaluate whether preoperative computed tomography (CT)-based bronchial diameter measurement improves the accuracy of initial DLT size selection compared with conventional selection based on demographic parameters. Eligible patients will be randomly assigned in a 1:1 ratio to either the CT-guided group or the conventional group.
Interventions
OTHERCT-Guided Group (Intervention)
Participants will undergo preoperative CT measurement of the bronchial diameter 10 mm distal to the carina. DLT size will be selected using manufacturer-recommended correlation charts based on CT measurements.
OTHERConventional Group (Control)
DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables.
Sponsors
King Hussein Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The anesthesiologist performing the intubation will remain blinded to group allocation and will not be informed whether the selected DLT size was based on CT measurements or conventional demographic-based criteria.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (≥18 years) scheduled for elective thoracic surgery requiring one-lung ventilation. 2. Availability of preoperative thoracic CT imaging. 3. Procedures requiring placement of a left-sided DLT. 4. Patient who has a normal pulmonary function test.
Exclusion criteria
1. Previous tracheal surgery 2. Patient with difficult airway whom need bronchial blocker. 3. Emergency thoracic procedures. 4. Incomplete intraoperative or imaging data. 5. Patient with severe obstruction or restriction. 6. Pediatric patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful selection of the correct DLT size on the first attempt (defined as optimal position and lung isolation without the need for tube exchange) using fiberoptic scope | During the intraoperative period (at first attempt of double-lumen tube placement) | the correct placement of a double-lumen tube (DLT) on the first attempt, achieving optimal tracheobronchial position and effective lung isolation as confirmed by fiberoptic bronchoscopy, without the need for tube exchange or repositioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DLT replacement | Intraoperative period (from initial DLT placement until end of surgery) | Number of participants requiring replacement of the double-lumen tube (DLT) after initial placement due to incorrect size, malposition, or inadequate lung isolation |
| Time required for successful intubation | Intraoperative period (from DLT insertion to confirmed successful placement) | Time (in seconds) from insertion of the double-lumen tube into the mouth until successful tracheal placement and confirmation of correct positioning and lung isolation |
| Frequency of intraoperative hypoxia and peak airway pressure fluctuations | Intraoperative period (from DLT insertion to confirmed successful placement) | Incidence of episodes of intraoperative hypoxia and measurement of peak airway pressure fluctuations during one-lung ventilation. |
| Blinded assessment of surgeon satisfaction (lung isolation quality) | At the end of surgery (intraoperative assessment) | Surgeon satisfaction with lung isolation quality assessed using a standardized scoring scale, evaluated in a blinded manner at the end of the surgical procedure. |
| Post-operative sore throat or airway trauma | 24 hours post-extubation | Incidence and severity of post-operative sore throat and/or signs of airway trauma (e.g., hoarseness, blood on suctioning, or mucosal injury if assessed) within 24 hours after extubation. |
Countries
Jordan
Contacts
CONTACTMoh'D Yousef, Consultant
CONTACTAhmad Al Kharabsheh, Fellow physician
PRINCIPAL_INVESTIGATORMoh'D Yousef, Consultant, Anesthesiology
King Hussein Cancer Center
Outcome results
None listed