NCT01533012

Brief Summary

The purpose of this study is to investigate a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2012

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

February 7, 2012

Last Update Submit

January 8, 2019

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Fiberoptic bronchoscopy view

    1. aucsultation under manual ventilation -\> fiberopric bronchoscopy view check 2. peak inspiratory pressure difference under mechanical ventilation -\> fiberoptic bronchoscopy view check

    within 5 min after intubation

Secondary Outcomes (1)

  • depth of double lumen tube

    within 5 min after checking fiberopitics

Study Arms (2)

Pressure difference

EXPERIMENTAL

Peak inspiratory pressures difference between two lungs

Procedure: Pressure difference

FOB evaluation

NO INTERVENTION

FOB evaluation for the optimal position of tubes

Interventions

Pressure differencePROCEDURE

Peak inspiratory pressures difference between two lungs

Pressure difference

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status class I, II
  • Use of double lumen tube
  • Normal preoperative pulmonary function study

You may not qualify if:

  • COPD
  • Restrictive lung disease
  • CAOD
  • Unstable hemodynamic status
  • Peak inspiratory pressure \> 30 mm Hg (Two lung ventilation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Kim SH, Choi YS, Shin S, Cho JS, Nam DJ, Oh YJ. Positioning of double-lumen tubes based on the minimum peak inspiratory pressure difference between the right and left lungs in short patients: a prospective observational study. Eur J Anaesthesiol. 2014 Mar;31(3):137-42. doi: 10.1097/EJA.0b013e328364c3a7.

    PMID: 24047768DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

October 25, 2012

Study Completion

October 25, 2012

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

KR(1)