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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-Guided Group | Experimental | 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. |
|
| Conventional Group | Active Comparator | DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-Guided Group (Intervention) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | During the intraoperative period (at first attempt of double-lumen tube placement) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT replacement | Number of participants requiring replacement of the double-lumen tube (DLT) after initial placement due to incorrect size, malposition, or inadequate lung isolation | Intraoperative period (from initial DLT placement until end of surgery) |
| Time required for successful intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moh'D Yousef, Consultant | Contact | +962796420055 | MY.16674@KHCC.JO | |
| Ahmad Al Kharabsheh, Fellow physician | Contact | 00962-796420055 | AA.15386@KHCC.JO |
| Name | Affiliation | Role |
|---|---|---|
| Moh'D Yousef, Consultant, Anesthesiology | King Hussein Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Hussein Cancer Center | Amman | 11941 | Jordan |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
| Conventional Group (Control) | Other | DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables. |
|
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 |
| Intraoperative period (from DLT insertion to confirmed successful placement) |
| Frequency of intraoperative hypoxia and peak airway pressure fluctuations | Incidence of episodes of intraoperative hypoxia and measurement of peak airway pressure fluctuations during one-lung ventilation. | Intraoperative period (from DLT insertion to confirmed successful placement) |
| Blinded assessment of surgeon satisfaction (lung isolation quality) | Surgeon satisfaction with lung isolation quality assessed using a standardized scoring scale, evaluated in a blinded manner at the end of the surgical procedure. | At the end of surgery (intraoperative assessment) |
| Post-operative sore throat or airway trauma | 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. | 24 hours post-extubation |