NCT07575763

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 ventilatio

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Thoracic SurgeryOne-lung Ventilation

Keywords

Double-lumen tubeThoracic anesthesiaCT-guided intubationOne-lung ventilation

Outcome Measures

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.

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

Secondary Outcomes (5)

  • Incidence of DLT replacement

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

  • Time required for successful intubation

    Intraoperative period (from DLT insertion to confirmed successful placement)

  • Frequency of intraoperative hypoxia and peak airway pressure fluctuations

    Intraoperative period (from DLT insertion to confirmed successful placement)

  • Blinded assessment of surgeon satisfaction (lung isolation quality)

    At the end of surgery (intraoperative assessment)

  • Post-operative sore throat or airway trauma

    24 hours post-extubation

Study Arms (2)

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.

Other: CT-Guided Group (Intervention)

Conventional Group

ACTIVE COMPARATOR

DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables.

Other: Conventional Group (Control)

Interventions

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.

CT-Guided Group
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.

Conventional Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous tracheal surgery
  • Patient with difficult airway whom need bronchial blocker.
  • Emergency thoracic procedures.
  • Incomplete intraoperative or imaging data.
  • Patient with severe obstruction or restriction.
  • Pediatric patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Moh'D Yousef, Consultant, Anesthesiology

    King Hussein Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moh'D Yousef, Consultant

CONTACT

+962796420055MY.16674@KHCC.JO

Ahmad Al Kharabsheh, Fellow physician

CONTACT

00962-796420055AA.15386@KHCC.JO

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The anesthesiologist performing intubation will be blinded to group allocation and will not be informed whether the assigned DLT size was determined by CT measurements or conventional demographic-based methods.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 2, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

JO(1)