Bronchial HemorrhageNCT05417295
Bronchial Injury Caused by Bronchial Cuff
A study testing Inflating air into the bronchial cuff before changing position and Inflating air into the bronchial cuff after changing position in people with Bronchial Hemorrhage, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Bronchial Hemorrhage
- What is being tested?
- Inflating air into the bronchial cuff before changing position and Inflating air into the bronchial cuff after changing position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube
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.
Read the 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.
- Conditions
- Bronchial Hemorrhage
- Being tested
- Inflating air into the bronchial cuff before changing position, Inflating air into the bronchial cuff after changing position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflating air into the bronchial cuff before changing positionProcedure or surgery
Inflating air into the bronchial cuff before or after changing position
Inflating air into the bronchial cuff after changing positionProcedure or surgery
Inflating air into the bronchial cuff after changing position
| Study group | Role | What they receive |
|---|---|---|
| Inflating air into the bronchial cuff before changing position | Experimental | 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. Receives: Procedure: Inflating air into the bronchial cuff before changing position |
| Inflating air into the bronchial cuff after changing position | Placebo comparator | Do not inflate air into the bronchial cuff before changing position. Receives: Procedure: Inflating air into the bronchial cuff after changing position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left bronchial mucosal injury
Degree of left bronchial mucosal injury is recorded via bronchoscope. Intact = 0 Redness = 1 Swelling = 2 hematoma = 3 Bleeding = 4
Measured: Before extubation
Secondary outcomes (1)
Displacement of double lumen endotracheal tube
Displacement of double lumen endotracheal tube after changing position
Measured: After changing into lateral position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417295
- Sponsor's protocol ID
- KMUHIRB-F(II)-20210164
- Status last verified
- Mar 2022
- First submitted
- 19 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT05417295
- Acronym / sponsor ID
- KMUHIRB-F(II)-20210164
- Conditions
- Bronchial Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflating air into the bronchial cuff before changing position | Experimental | Procedure: Inflating air into the bronchial cuff before changing positionBefore 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. |
| Inflating air into the bronchial cuff after changing position | Placebo comparator | Procedure: Inflating air into the bronchial cuff after changing positionDo not inflate air into the bronchial cuff before changing position. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflating air into the bronchial cuff before changing positionInflating air into the bronchial cuff before or after changing position | Procedure or surgery | Inflating air into the bronchial cuff before changing position |
| Inflating air into the bronchial cuff after changing positionInflating air into the bronchial cuff after changing position | Procedure or surgery | Inflating air into the bronchial cuff after changing position |
Primary outcome
Left bronchial mucosal injury
Time frame: Before extubation
Degree of left bronchial mucosal injury is recorded via bronchoscope. Intact = 0 Redness = 1 Swelling = 2 hematoma = 3 Bleeding = 4
1 secondary outcome
Displacement of double lumen endotracheal tube
Time frame: After changing into lateral position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Inflating air into the bronchial cuff before changing position and Inflating air into the bronchial cuff after changing position in people with Bronchial Hemorrhage, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Wei Ma, Kaohsiung Medical University (+886-7-3121101 #7035, warpike@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left bronchial mucosal injury (time frame: Before extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.