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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
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pneumothorax

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 27, 2015
    Last Updated
    November 4, 2018
    Sponsor
    Ajou University School of Medicine
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    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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