NCT01413347

Brief Summary

The purpose of this study is to devise the method to reduce displacement of a left-sided double-lumen tube during patient positioning.

Trial Health

87
On Track

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
Completed

Started Aug 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

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

August 9, 2011

Last Update Submit

December 7, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • tracheal displacement

    up to 5 minutes

Secondary Outcomes (1)

  • bronchial displacement

    up to 5 minutes

Study Arms (2)

pillow

ACTIVE COMPARATOR

confirmation of double-lumen tube position with a head on a pillow

Procedure: pillow

neutral

EXPERIMENTAL

confirmation of double-lumen tube position in neutral position of a head

Procedure: neutral

Interventions

pillowPROCEDURE

bronchoscopic confirmation of double-lumen tube position with a head on a pillow

pillow
neutralPROCEDURE

bronchoscopic confirmation of double-lumen tube position in neutral position of a head

neutral

Eligibility Criteria

Age18 Years - 80 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:

  • intraluminal lesion of left bronchus
  • very distorted anatomy of tracheobronchial tree

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Seo JH, Hong DM, Lee JM, Chung EJ, Bahk JH. Double-lumen tube placement with the patient in the supine position without a headrest minimizes displacement during lateral positioning. Can J Anaesth. 2012 May;59(5):437-41. doi: 10.1007/s12630-012-9679-7. Epub 2012 Feb 25.

Study Design

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

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations