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Bronchial Injury Caused by Bronchial Cuff

Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05417295
Enrollment
60
Registered
2022-06-14
Start date
2022-07-31
Completion date
2023-07-31
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Hemorrhage

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.

Interventions

PROCEDUREInflating air into the bronchial cuff before changing position

Inflating air into the bronchial cuff before or after changing position

PROCEDUREInflating air into the bronchial cuff after changing position

Inflating air into the bronchial cuff after changing position

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Displacement of double lumen endotracheal tubeAfter changing into lateral positionDisplacement of double lumen endotracheal tube after changing position

Contacts

Primary ContactChao-Wei Ma, Kaohsiung Medical University
warpike@yahoo.com.tw+886-7-3121101 #7035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026