CT-Guided vs Conventional DLT Sizing in Thoracic Surgery (CTDLT-SIZE)

CT-Guided Versus Traditional Selection of Double-Lumen Tube Size for One-Lung Ventilation in Thoracic Surgery: A Prospective Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Surgery; One-lung Ventilation
• Intervention / Treatment: Other: CT-Guided Group (Intervention); Other: Conventional Group (Control)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moh'D Yousef, Consultant; Phone Number: +962796420055; Email: MY.16674@KHCC.JO
• Study Contact Backup: Name: Ahmad Al Kharabsheh, Fellow physician; Phone Number: 00962-796420055; Email: AA.15386@KHCC.JO

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • King Hussein Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-Guided Group; 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.	Other: CT-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.
Active Comparator: Conventional Group; DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables.	Other: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: King Hussein Cancer Center
• Investigators: Principal Investigator: Moh'D Yousef, Consultant, Anesthesiology, King Hussein Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 2, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: One-lung ventilation; Thoracic anesthesia; Double-lumen tube; CT-guided intubation
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 26 KHCC 59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No