King Hussein Cancer Center
Amman, 11941, Jordan
NCT Number: NCT07575763
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Amman, 11941, Jordan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables.
Time frame: 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.
Time frame: 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 frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ahmad Al Kharabsheh, Fellow physician
CONTACT
Moh'D Yousef, Consultant
CONTACT
King Hussein Cancer Center
Other
CT-Guided Versus Traditional Selection of Double-Lumen Tube Size for One-Lung Ventilation in Thoracic Surgery: A Prospective Study
Acronym: CTDLT-SIZE
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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.
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