NCT01818128

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

March 18, 2013

Last Update Submit

May 20, 2015

Conditions

Double Lumen Tube Intubation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with intubation to right mainstem bronchus

    An expected average of 5minutes after intubation

Secondary Outcomes (1)

  • Number of participants with airway injury

    An expected average of 5 minutes after bilateral lung ventilation

Study Arms (2)

Neutral shape of bronchial tip

ACTIVE COMPARATOR
Device: Neutral shape of bronchial tip

Bent shape of bronchial tip

EXPERIMENTAL
Device: Bent shape of bronchial tip

Interventions

Neutral shape of bronchial tipDEVICE

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

Neutral shape of bronchial tip
Bent shape of bronchial tipDEVICE

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

Bent shape of bronchial tip

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 26, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

KR(1)