Bronchial Cuff Volume at Air-tight SealNCT01818102

CT Window Setting to Select Double-lumen Tube Size

A study testing Width 1000 HU/Level -450 HU and Width 400 HU/Level 25 HU in people with Bronchial Cuff Volume at Air-tight Seal and Intracuff Cuff Pressure at Air-tighe Seal, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube. Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Bronchial Cuff Volume at Air-tight Seal, Intracuff Cuff Pressure at Air-tighe Seal
What is being tested?: Width 1000 HU/Level -450 HU and Width 400 HU/Level 25 HU
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 1 siteSouth Korea
Study dates: Feb 2013to Feb 2014
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 that require the placement of left-sided double-lumen tubes

Who cannot join

Abnoraml anatomy of tracheobronchail tree
Intraluminal lesion in the left mainstem bronchus
Anticipated difficult intubation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.

Conditions: Bronchial Cuff Volume at Air-tight Seal, Intracuff Cuff Pressure at Air-tighe Seal
Being tested: Width 1000 HU/Level -450 HU, Width 400 HU/Level 25 HU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Width 1000 HU/Level -450 HUDevice
Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.
Width 400 HU/Level 25 HUDevice
Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.

Study groups in NCT01818102
Study group	Role	What they receive
Width 1000 HU/Level -450 HU	Experimental	Not described Receives: Device: Width 1000 HU/Level -450 HU
Width 400 HU/Level 25 HU	Active comparator	Not described Receives: Device: Width 400 HU/Level 25 HU

What is being measured

The primary outcome is the main question the study is designed to answer.

Air-leak at deflation of bronchial cuff
Measured: An expected average of 10 min after double lumen tube intubation
Air-tight seal below resting volume of bronchial cuff
Measured: An expected average of 10 min after double lumen tube intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Feb 2014

First posted26 Mar 2013 (estimated)
Study startFeb 2013
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bronchial Cuff Volume at Air-tight SealStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 228 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01818102
Sponsor's protocol ID: JHBahk_DLT_CT window
Status last verified: May 2015
First submitted: 18 Mar 2013
Last updated: 22 May 2015
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CT Window Setting to Select Double-lumen Tube Size
ClinicalTrials.gov ID: NCT01818102
Acronym / sponsor ID: JHBahk_DLT_CT window
Conditions: Bronchial Cuff Volume at Air-tight Seal, Intracuff Cuff Pressure at Air-tighe Seal
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Feb 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 26 Mar 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 investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Width 1000 HU/Level -450 HU	Experimental	Device: Width 1000 HU/Level -450 HU
Width 400 HU/Level 25 HU	Active comparator	Device: Width 400 HU/Level 25 HU

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Key exclusion criteria (3 listed)

Abnoraml anatomy of tracheobronchail tree
Intraluminal lesion in the left mainstem bronchus
Anticipated difficult intubation

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
Width 1000 HU/Level -450 HUDouble-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.	Device	Width 1000 HU/Level -450 HU
Width 400 HU/Level 25 HUDouble-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.	Device	Width 400 HU/Level 25 HU

Primary outcome

Air-leak at deflation of bronchial cuff
Time frame: An expected average of 10 min after double lumen tube intubation
Air-tight seal below resting volume of bronchial cuff
Time frame: An expected average of 10 min after double lumen tube intubation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 22 May 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Air-leak at deflation of bronchial cuff (time frame: An expected average of 10 min after double lumen tube intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01818102.

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 22 May 2015.