Thoracic SurgeryNCT01533012
Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
A study testing Pressure difference in people with Thoracic Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Pressure difference
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2012to 25 Oct 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class I, II
- Use of double lumen tube
- Normal preoperative pulmonary function study
Who cannot join
- COPD
- Restrictive lung disease
- CAOD
- Unstable hemodynamic status
- Peak inspiratory pressure > 30 mm Hg (Two lung ventilation)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
The purpose of this study is to investigate a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs.
Read the detailed description
If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory position, peak inspiratory pressure between two lungs is similar or equal when each lumen is sequentially clamped while ventilating each lung with the same tidal volume. We are going to investigate a performance of this method by fiberoptic bronchoscopy view and depth of double lumen tube, and compare with an conventional auscultation method.
- Conditions
- Thoracic Surgery
- Being tested
- Pressure difference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure differenceProcedure or surgery
Peak inspiratory pressures difference between two lungs
| Study group | Role | What they receive |
|---|---|---|
| Pressure difference | Experimental | Peak inspiratory pressures difference between two lungs Receives: Procedure: Pressure difference |
| FOB evaluation | No intervention | FOB evaluation for the optimal position of tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiberoptic bronchoscopy view
- aucsultation under manual ventilation -> fiberopric bronchoscopy view check
- peak inspiratory pressure difference under mechanical ventilation -> fiberoptic bronchoscopy view check
Measured: within 5 min after intubation
Secondary outcomes (1)
depth of double lumen tube
- aucsultation under manual ventilation -> A depth of DLT (incisor)
- peak inspiratory pressure difference under mechanical ventilation -> A depth of DLT (incisor)
Measured: within 5 min after checking fiberopitics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study start1 Feb 2012
- Primary completion25 Oct 2012
- Study completion25 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533012
- Sponsor's protocol ID
- 4-2011-0619
- Status last verified
- Jan 2019
- First submitted
- 7 Feb 2012
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SH, Choi YS, Shin S, Cho JS, Nam DJ, Oh YJ. Positioning of double-lumen tubes based on the minimum peak inspiratory pressure difference between the right and left lungs in short patients: a prospective observational study. Eur J Anaesthesiol. 2014 Mar;31(3):137-42. doi: 10.1097/EJA.0b013e328364c3a7.
PubMed 24047768
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
- ClinicalTrials.gov ID
- NCT01533012
- Acronym / sponsor ID
- 4-2011-0619
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 25 Oct 2012 (actual)
- Study completion
- 25 Oct 2012 (actual)
- First posted
- 15 Feb 2012 (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 a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs.
Detailed description
If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory position, peak inspiratory pressure between two lungs is similar or equal when each lumen is sequentially clamped while ventilating each lung with the same tidal volume. We are going to investigate a performance of this method by fiberoptic bronchoscopy view and depth of double lumen tube, and compare with an conventional auscultation method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure difference | Experimental | Procedure: Pressure differencePeak inspiratory pressures difference between two lungs |
| FOB evaluation | No intervention | –FOB evaluation for the optimal position of tubes |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status class I, II
- Use of double lumen tube
- Normal preoperative pulmonary function study
Key exclusion criteria (5 listed)
- COPD
- Restrictive lung disease
- CAOD
- Unstable hemodynamic status
- Peak inspiratory pressure > 30 mm Hg (Two lung ventilation)
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 |
|---|---|---|
| Pressure differencePeak inspiratory pressures difference between two lungs | Procedure or surgery | Pressure difference |
Primary outcome
Fiberoptic bronchoscopy view
Time frame: within 5 min after intubation
1. aucsultation under manual ventilation -> fiberopric bronchoscopy view check 2. peak inspiratory pressure difference under mechanical ventilation -> fiberoptic bronchoscopy view check
1 secondary outcome
depth of double lumen tube
Time frame: within 5 min after checking fiberopitics
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 10 Jan 2019.
- Derived from this study: PubMed 24047768Kim SH, Choi YS, Shin S, Cho JS, Nam DJ, Oh YJ. Positioning of double-lumen tubes based on the minimum peak inspiratory pressure difference between the right and left lungs in short patients: a prospective observational study. Eur J Anaesthesiol. 2014 Mar;31(3):137-42. doi: 10.1097/EJA.0b013e328364c3a7.
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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.
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?
A study testing Pressure difference in people with Thoracic Surgery, run by Yonsei University 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 3 inclusion and 5 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 10 Jan 2019. 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?
Fiberoptic bronchoscopy view (time frame: within 5 min after intubation). 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 NCT01533012, which also lists 1 linked publication.
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 10 Jan 2019.