Health Trials

CT-Guided vs Conventional DLT Sizing in Thoracic Surgery

ConditionsThoracic SurgeryOne-lung Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Hussein Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years) scheduled for elective thoracic surgery requiring one-lung ventilation.

Availability of preoperative thoracic CT imaging.

Procedures requiring placement of a left-sided DLT.

Patient who has a normal pulmonary function test.

Disqualifiers

Previous tracheal surgery

Patient with difficult airway whom need bronchial blocker.

Emergency thoracic procedures.

Incomplete intraoperative or imaging data.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CT-Guided Group (Intervention)

    Other 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.

  • Conventional Group (Control)

    Other intervention

    DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CT-Guided GroupExperimental treatment 1 intervention
Group B: Conventional GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During the intraoperative period (at first attempt of double-lumen tube placement)

Secondary outcomes

1

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

Time frame
Intraoperative period (from initial DLT placement until end of surgery)
2

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

Time frame
Intraoperative period (from DLT insertion to confirmed successful placement)
3

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.

Time frame
Intraoperative period (from DLT insertion to confirmed successful placement)
4

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.

Time frame
At the end of surgery (intraoperative assessment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Hussein Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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