Utility of Disconnection Technique for One Lung Ventilation
Primary Purpose
Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
disconnection technique
Sponsored by
About this trial
This is an interventional other trial for Pneumothorax
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for wedge resection for pneumothorax, unilateral
- ASA class I, II
Exclusion Criteria:
- know lung disease
- any kind of lung abnormality on preoperative chest x-ray
- coronary artery occlusive disease
- cerebrovascular disease
- pregnancy
- unable to understand the informed consent form
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DLT(Double Lumen Tube) group
BB(Bronchial Blocker) group
Arm Description
disconnection technique will be applied
disconnection technique will be applied
Outcomes
Primary Outcome Measures
Lung deflation score
verbal analog scale(0=no deflation, 10=complete deflation)
Secondary Outcome Measures
time for initial placement
time for lung deflation
Full Information
NCT ID
NCT02644642
First Posted
December 27, 2015
Last Updated
November 4, 2018
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02644642
Brief Title
Utility of Disconnection Technique for One Lung Ventilation
Official Title
Utility of Disconnection Technique for One Lung Ventilation: a Comparison of a Double Lumen Endobronchial Tube With a Bronchial Blocker
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. However, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. Therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DLT(Double Lumen Tube) group
Arm Type
Experimental
Arm Description
disconnection technique will be applied
Arm Title
BB(Bronchial Blocker) group
Arm Type
Experimental
Arm Description
disconnection technique will be applied
Intervention Type
Other
Intervention Name(s)
disconnection technique
Intervention Description
Before lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker.
Primary Outcome Measure Information:
Title
Lung deflation score
Description
verbal analog scale(0=no deflation, 10=complete deflation)
Time Frame
10 min after inflation of balloon
Secondary Outcome Measure Information:
Title
time for initial placement
Time Frame
from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
Title
time for lung deflation
Time Frame
from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for wedge resection for pneumothorax, unilateral
ASA class I, II
Exclusion Criteria:
know lung disease
any kind of lung abnormality on preoperative chest x-ray
coronary artery occlusive disease
cerebrovascular disease
pregnancy
unable to understand the informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Go Un Roh, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Utility of Disconnection Technique for One Lung Ventilation
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