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

About this trial
This is an interventional prevention trial for Bronchial Hemorrhage
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.
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
NCT ID
NCT05417295
First Posted
May 19, 2022
Last Updated
June 9, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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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