NCT01441362

Brief Summary

The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

September 25, 2011

Last Update Submit

February 16, 2012

Conditions

Laryngeal Injuries

Keywords

during double-lumentube intubation

Outcome Measures

Primary Outcomes (1)

  • postoperative hoarseness

    up to 3 days

Secondary Outcomes (1)

  • postoperative sore throat

    up to 3 days

Study Arms (2)

90 degrees rotation

ACTIVE COMPARATOR

Double-lumen tube intubation with 90 degrees rotation

Procedure: 90 degrees rotation

180 degrees rotation

EXPERIMENTAL

Double-lumen tube intubation with 180 degrees rotation

Procedure: 180 degrees rotation

Interventions

90 degrees rotationPROCEDURE

Double-lumen tube intubation with 90 degrees rotation

90 degrees rotation
180 degrees rotationPROCEDURE

Double-lumen tube intubation with 180 degrees rotation

180 degrees rotation

Eligibility Criteria

Age20 Years - 75 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:

  • Preoperative hoarseness or sore throat
  • History of upper airway diseases
  • Anticipated difficult airway
  • Operation time longer than 6 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Seo JH, Kwon TK, Jeon Y, Hong DM, Kim HJ, Bahk JH. Comparison of techniques for double-lumen endobronchial intubation: 90 degrees or 180 degrees rotation during advancement through the glottis. Br J Anaesth. 2013 Nov;111(5):812-7. doi: 10.1093/bja/aet203. Epub 2013 Jun 20.

    PMID: 23794671DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 27, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

KR(1)