Preventing Blood Leakage of Bronchial CuffNCT01979640
Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube
A study testing 39 Fr double lumen tube group, 37 Fr double lumen tube group and 35 Fr double lumen tube group in people with Preventing Blood Leakage of Bronchial Cuff, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Preventing Blood Leakage of Bronchial Cuff
- What is being tested?
- 39 Fr double lumen tube group, 37 Fr double lumen tube group and 35 Fr double lumen tube group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Dec 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
- patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube
Who cannot join
- dislocation or great movement of double lumen tube depth
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jae-Hyon Bahk, MD, PhD, 82-2-2072-2818, bahkjh@snu.ac.kr
About this study
The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube
- Being tested
- 39 Fr double lumen tube group, 37 Fr double lumen tube group, 35 Fr double lumen tube group
- Keywords
- bronchial cuff, double lumen tube, blood tight seal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
39 Fr double lumen tube groupProcedure or surgery
additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
37 Fr double lumen tube groupProcedure or surgery
additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
35 Fr double lumen tube groupProcedure or surgery
additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
| Study group | Role | What they receive |
|---|---|---|
| 39 Fr double lumen group | Experimental | patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube Receives: Procedure: 39 Fr double lumen tube group |
| 37 Fr double lumen group | Experimental | patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube Receives: Procedure: 37 Fr double lumen tube group |
| 35 Fr double lumen tube group | Experimental | patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube Receives: Procedure: 35 Fr double lumen tube group |
What is being measured
The primary outcome is the main question the study is designed to answer.
leakage of autologus blood through bronchial cuff
Measured: 10, 20, 30 minutes after dripping of blood around bronchial cuff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventing Blood Leakage of Bronchial CuffStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979640
- Sponsor's protocol ID
- JHBahk_DLT_bloodtightseal
- Status last verified
- Apr 2016
- First submitted
- 3 Nov 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube
- ClinicalTrials.gov ID
- NCT01979640
- Acronym / sponsor ID
- JHBahk_DLT_bloodtightseal
- Keywords
- bronchial cuff, double lumen tube, blood tight seal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 39 Fr double lumen group | Experimental | Procedure: 39 Fr double lumen tube grouppatients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube |
| 37 Fr double lumen group | Experimental | Procedure: 37 Fr double lumen tube grouppatients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube |
| 35 Fr double lumen tube group | Experimental | Procedure: 35 Fr double lumen tube grouppatients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
- patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube
Key exclusion criteria (1 listed)
- dislocation or great movement of double lumen tube depth
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 |
|---|---|---|
| 39 Fr double lumen tube groupadditional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml | Procedure or surgery | 39 Fr double lumen group |
| 37 Fr double lumen tube groupadditional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml | Procedure or surgery | 37 Fr double lumen group |
| 35 Fr double lumen tube groupadditional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml | Procedure or surgery | 35 Fr double lumen tube group |
Primary outcome
leakage of autologus blood through bronchial cuff
Time frame: 10, 20, 30 minutes after dripping of blood around bronchial cuff
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 39 Fr double lumen tube group, 37 Fr double lumen tube group and 35 Fr double lumen tube group in people with Preventing Blood Leakage of Bronchial Cuff, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 Jae-Hyon Bahk, MD, PhD (82-2-2072-2818, bahkjh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leakage of autologus blood through bronchial cuff (time frame: 10, 20, 30 minutes after dripping of blood around bronchial cuff). 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 20 Apr 2016.