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Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs

Primary Purpose

Thoracic Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pressure difference
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pressure difference

FOB evaluation

Arm Description

Peak inspiratory pressures difference between two lungs

FOB evaluation for the optimal position of tubes

Outcomes

Primary Outcome Measures

Fiberoptic bronchoscopy view
aucsultation under manual ventilation -> fiberopric bronchoscopy view check peak inspiratory pressure difference under mechanical ventilation -> fiberoptic bronchoscopy view check

Secondary Outcome Measures

depth of double lumen tube
aucsultation under manual ventilation -> A depth of DLT (incisor) peak inspiratory pressure difference under mechanical ventilation -> A depth of DLT (incisor)

Full Information

First Posted
February 7, 2012
Last Updated
January 8, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01533012
Brief Title
Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
Official Title
Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
October 25, 2012 (Actual)
Study Completion Date
October 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory position, peak inspiratory pressure between two lungs is similar or equal when each lumen is sequentially clamped while ventilating each lung with the same tidal volume. We are going to investigate a performance of this method by fiberoptic bronchoscopy view and depth of double lumen tube, and compare with an conventional auscultation method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure difference
Arm Type
Experimental
Arm Description
Peak inspiratory pressures difference between two lungs
Arm Title
FOB evaluation
Arm Type
No Intervention
Arm Description
FOB evaluation for the optimal position of tubes
Intervention Type
Procedure
Intervention Name(s)
Pressure difference
Intervention Description
Peak inspiratory pressures difference between two lungs
Primary Outcome Measure Information:
Title
Fiberoptic bronchoscopy view
Description
aucsultation under manual ventilation -> fiberopric bronchoscopy view check peak inspiratory pressure difference under mechanical ventilation -> fiberoptic bronchoscopy view check
Time Frame
within 5 min after intubation
Secondary Outcome Measure Information:
Title
depth of double lumen tube
Description
aucsultation under manual ventilation -> A depth of DLT (incisor) peak inspiratory pressure difference under mechanical ventilation -> A depth of DLT (incisor)
Time Frame
within 5 min after checking fiberopitics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status class I, II Use of double lumen tube Normal preoperative pulmonary function study Exclusion Criteria: COPD Restrictive lung disease CAOD Unstable hemodynamic status Peak inspiratory pressure > 30 mm Hg (Two lung ventilation)
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24047768
Citation
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.
Results Reference
derived

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Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs

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