The Direction of Blocker PlacementNCT06595043
Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation
A study testing the tip opening angle to the left and the tip opening angle to the right in people with The Direction of Blocker Placement, run by China Medical University, China at 3 sites in 3 countries.
Trial summary
This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Direction of Blocker Placement
- What is being tested?
- the tip opening angle to the left and the tip opening angle to the right
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Oct 2024to 31 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranged from 18 to 65 years old;
- American Society of Anesthesiologists (ASA) grade I-III;
- No history of drug allergy or abnormal anesthesia;
- Patients undergoing right thoracoscopic surgery;
- The preoperative oxygen saturation was not less than 94%.
Who cannot join
- Patients with a history of acute lung injury or ARDS within 3 months;
- Cardiac function class IV (New York Heart Association classification);
- Chronic renal failure (renal cell filtration rate <30ml min-11.73m-2), severe liver disease;
- Patients with blurred consciousness and cognitive dysfunction;
- Patients with severe coagulation dysfunction;
- Without preoperative oxygen inhalation, blood oxygen <94%, severe pulmonary dysfunction;
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- Patients with endotracheal tube admitted to ICU after operation;
- Body mass index (BMI) >30;
- Patients who had had lung surgery；
- Inability to complete the study;
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Serbia1 site, 1 recruiting
- Not yet recruiting
the University Clinical Center of Serbia
Belgrade
Marina Stojanović, marinailicstojanovic@gmail.com
South Korea1 site, 1 recruiting
- Not yet recruiting
Konkuk University School of Medicine
Seoul
Tae-Yop Kim, taeyop@hotmail.com
About this study
Official title: Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial
This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. The investigators aim to investigate the effect of different occlusion angles of disposable tracheal blocker on right one-lung ventilation
Read the detailed description
This trial is a practical, multi-center, prospective, parallel grouping, randomized controlled,two-arm clinical study comparing the different occlusion angles of disposable tracheal blocker on right one-lung ventilation. It is planned to enroll 96 subjects requiring right-sided One-Lung ventilation, aged 18-65 years, at three centers. Patients will be randomly assigned to the tip opening angle to the right (Group R), or he tip opening angle to the left (Group L). The primary outcome is the satisfaction with intraoperative collapse of the right lung. The secondary outcome is the one-time success rate of occuder implantation
- Conditions
- The Direction of Blocker Placement
- Being tested
- the tip opening angle to the left, the tip opening angle to the right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the tip opening angle to the leftDevice
After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope.
the tip opening angle to the rightDevice
After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| the tip opening angle to the left | Experimental | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope. Receives: Device: the tip opening angle to the left |
| the tip opening angle to the right | Placebo comparator | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope. Receives: Device: the tip opening angle to the right |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the collapse of the right lung
The pirimary outcome is the comparison the effects of different occluder opening directions on lung collapse by one surgeon using lung collapse score (1-4, 4 means the best)
Measured: On the 3 minutes after one lung ventilation
Secondary outcomes (1)
The first time success rate of blocker implantation
The first time success rate of blocker implantation
Measured: On the time of blocker implantation 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024 (estimated)
- Primary completion9 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Direction of Blocker PlacementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenfei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595043
- Sponsor's protocol ID
- 20240910
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06595043
- Acronym / sponsor ID
- 20240910
- Conditions
- The Direction of Blocker Placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 9 Oct 2024 (estimated)
- Primary completion
- 9 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. The investigators aim to investigate the effect of different occlusion angles of disposable tracheal blocker on right one-lung ventilation
Detailed description
This trial is a practical, multi-center, prospective, parallel grouping, randomized controlled,two-arm clinical study comparing the different occlusion angles of disposable tracheal blocker on right one-lung ventilation. It is planned to enroll 96 subjects requiring right-sided One-Lung ventilation, aged 18-65 years, at three centers. Patients will be randomly assigned to the tip opening angle to the right (Group R), or he tip opening angle to the left (Group L). The primary outcome is the satisfaction with intraoperative collapse of the right lung. The secondary outcome is the one-time success rate of occuder implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the tip opening angle to the left | Experimental | Device: the tip opening angle to the leftAfter fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope. |
| the tip opening angle to the right | Placebo comparator | Device: the tip opening angle to the rightAfter fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ranged from 18 to 65 years old;
- American Society of Anesthesiologists (ASA) grade I-III;
- No history of drug allergy or abnormal anesthesia;
- Patients undergoing right thoracoscopic surgery;
- The preoperative oxygen saturation was not less than 94%.
Key exclusion criteria (10 listed)
- Patients with a history of acute lung injury or ARDS within 3 months;
- Cardiac function class IV (New York Heart Association classification);
- Chronic renal failure (renal cell filtration rate <30ml min-11.73m-2), severe liver disease;
- Patients with blurred consciousness and cognitive dysfunction;
- Patients with severe coagulation dysfunction;
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 |
|---|---|---|
| the tip opening angle to the leftAfter fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope. | Device | the tip opening angle to the left |
| the tip opening angle to the rightAfter fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope. | Device | the tip opening angle to the right |
Primary outcome
Satisfaction with the collapse of the right lung
Time frame: On the 3 minutes after one lung ventilation
The pirimary outcome is the comparison the effects of different occluder opening directions on lung collapse by one surgeon using lung collapse score (1-4, 4 means the best)
1 secondary outcome
The first time success rate of blocker implantation
Time frame: On the time of blocker implantation 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the tip opening angle to the left and the tip opening angle to the right in people with The Direction of Blocker Placement, run by China Medical University, China at 3 sites in 3 countries.
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 5 inclusion and 10 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Serbia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Wenfei Tan (02483283100, wftan@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the collapse of the right lung (time frame: On the 3 minutes after one lung ventilation). 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 19 Sep 2024.