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CompletedNCT01818128Updated May 22, 2015

The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus

An interventional study of Neutral shape of bronchial tip and Bent shape of bronchial tip in Double Lumen Tube Intubation, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-05-22.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,540
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.

02

Conditions studied

  • Double Lumen Tube Intubation
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion criteria

Exclusion Criteria:

  • Abnormal anatomy of tracheobronchial tree
  • Intraluminal lesion in the left or right mainstem bronchus
  • Anticipated difficult intubation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,540 participants (estimated)

Study arms

  • Active comparator
    Neutral shape of bronchial tip

    Device: Neutral shape of bronchial tip

  • Experimental
    Bent shape of bronchial tip

    Device: Bent shape of bronchial tip

Interventions

  • DeviceNeutral shape of bronchial tip

    Intubation is performed without transforming the shape of the bonchial tipof a double lumen tube.

  • DeviceBent shape of bronchial tip

    Intubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min.

06

What researchers measure

Primary outcomes

  1. Number of participants with intubation to right mainstem bronchus

    Time frame: An expected average of 5minutes after intubation

Secondary outcomes

  1. Number of participants with airway injury

    Time frame: An expected average of 5 minutes after bilateral lung ventilation

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818128
Responsible party
Jae-Hyon Bahk, MD, PhD (Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 26, 2013
Start date
Mar 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
May 22, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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