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Bronchial Injury Caused by Bronchial Cuff

Primary Purpose

Bronchial Hemorrhage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inflating air into the bronchial cuff before changing position
Inflating air into the bronchial cuff after changing position
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchial Hemorrhage

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.

Exclusion Criteria:

  • ASA status > III, coagulopathy, known airway damage, difficult intubation, tracheostomy, double lumen endotracheal tube is displaced during operation which interferes one lung ventilation and needs to be adjusted.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inflating air into the bronchial cuff before changing position

    Inflating air into the bronchial cuff after changing position

    Arm Description

    Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg.

    Do not inflate air into the bronchial cuff before changing position.

    Outcomes

    Primary Outcome Measures

    Left bronchial mucosal injury
    Degree of left bronchial mucosal injury is recorded via bronchoscope. Intact = 0 Redness = 1 Swelling = 2 hematoma = 3 Bleeding = 4

    Secondary Outcome Measures

    Displacement of double lumen endotracheal tube
    Displacement of double lumen endotracheal tube after changing position

    Full Information

    First Posted
    May 19, 2022
    Last Updated
    June 9, 2022
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05417295
    Brief Title
    Bronchial Injury Caused by Bronchial Cuff
    Official Title
    Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Double lumen endotracheal tubes (DLT) are wildly used to maintain independent lung ventilation during thoracic surgery. Our aim is to assess whether the DLT bronchial cuff inflated or not is associated with tube displacement and bronchial mucosal injury while changing position.
    Detailed Description
    Experiment group: Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg. Control group: Do not inflate air into the bronchial cuff before changing position. Main result: Degree of left bronchial mucosal injury. Secondary result: Displacement of double lumen endotracheal tube after changing position. All patients receive general anesthesia and are intubated with left DLT in the supine position. The fiberoptic bronchoscope is used to check the position via tracheal lumen of DLT. The bronchial lumen is placed at the left bronchus and the edge of bronchial cuff is visible by fiberscope. Before changing position, the bronchial cuff of experiment group is inflated with air and adjusted cuff pressure to 25-30 mmHg. Both groups of patient's neck are fixed by neck collar in order to prevent displacement of DLT by neck rotation. After changing into lateral position, the assistant inflates 2 ml of into the bronchial cuff of control group and adjust cuff pressure to 25-30 mmHg. The investigator, blinded to the tube assignments, uses the fiberoptic bronchoscope to check position of the tube again via tracheal lumen of DLT and record the distance of displacement. At the end of the surgery, both lumens of DLT are sucked and bronchial cuffs are deflated. After pulling out 3 cm of the DLT, the patient is changed into supine position and the fiberoptic bronchoscope is used to check the degree of bronchial injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchial Hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inflating air into the bronchial cuff before changing position
    Arm Type
    Experimental
    Arm Description
    Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg.
    Arm Title
    Inflating air into the bronchial cuff after changing position
    Arm Type
    Placebo Comparator
    Arm Description
    Do not inflate air into the bronchial cuff before changing position.
    Intervention Type
    Procedure
    Intervention Name(s)
    Inflating air into the bronchial cuff before changing position
    Intervention Description
    Inflating air into the bronchial cuff before or after changing position
    Intervention Type
    Procedure
    Intervention Name(s)
    Inflating air into the bronchial cuff after changing position
    Intervention Description
    Inflating air into the bronchial cuff after changing position
    Primary Outcome Measure Information:
    Title
    Left bronchial mucosal injury
    Description
    Degree of left bronchial mucosal injury is recorded via bronchoscope. Intact = 0 Redness = 1 Swelling = 2 hematoma = 3 Bleeding = 4
    Time Frame
    Before extubation
    Secondary Outcome Measure Information:
    Title
    Displacement of double lumen endotracheal tube
    Description
    Displacement of double lumen endotracheal tube after changing position
    Time Frame
    After changing into lateral position

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube. Exclusion Criteria: ASA status > III, coagulopathy, known airway damage, difficult intubation, tracheostomy, double lumen endotracheal tube is displaced during operation which interferes one lung ventilation and needs to be adjusted.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chao-Wei Ma, Kaohsiung Medical University
    Phone
    +886-7-3121101 #7035
    Email
    warpike@yahoo.com.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Bronchial Injury Caused by Bronchial Cuff

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