PneumothoraxNCT02644642
Utility of Disconnection Technique for One Lung Ventilation
A study testing disconnection technique in people with Pneumothorax, run by Ajou University School of Medicine.
Trial summary
Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- disconnection technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients scheduled for wedge resection for pneumothorax, unilateral
- ASA class I, II
Who cannot join
- know lung disease
- any kind of lung abnormality on preoperative chest x-ray
- coronary artery occlusive disease
- cerebrovascular disease
- pregnancy
- unable to understand the informed consent form
About this study
Official title: Utility of Disconnection Technique for One Lung Ventilation: a Comparison of a Double Lumen Endobronchial Tube With a Bronchial Blocker
Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. However, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. Therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated
- Conditions
- Pneumothorax
- Being tested
- disconnection technique
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disconnection techniqueOther
Before lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker.
| Study group | Role | What they receive |
|---|---|---|
| DLT(Double Lumen Tube) group | Experimental | disconnection technique will be applied Receives: Other: disconnection technique |
| BB(Bronchial Blocker) group | Experimental | disconnection technique will be applied Receives: Other: disconnection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung deflation score
verbal analog scale(0=no deflation, 10=complete deflation)
Measured: 10 min after inflation of balloon
Secondary outcomes (2)
time for initial placement
Measured: from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
time for lung deflation
Measured: from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
- Investigators
- Go Un Roh, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644642
- Sponsor's protocol ID
- AJIRB-MED-DEO-15-391
- Status last verified
- Nov 2018
- First submitted
- 27 Dec 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Disconnection Technique for One Lung Ventilation: a Comparison of a Double Lumen Endobronchial Tube With a Bronchial Blocker
- ClinicalTrials.gov ID
- NCT02644642
- Acronym / sponsor ID
- AJIRB-MED-DEO-15-391
- Conditions
- Pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jan 2016 (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.
Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. However, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. Therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLT(Double Lumen Tube) group | Experimental | Other: disconnection techniquedisconnection technique will be applied |
| BB(Bronchial Blocker) group | Experimental | Other: disconnection techniquedisconnection technique will be applied |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients scheduled for wedge resection for pneumothorax, unilateral
- ASA class I, II
Key exclusion criteria (6 listed)
- know lung disease
- any kind of lung abnormality on preoperative chest x-ray
- coronary artery occlusive disease
- cerebrovascular disease
- pregnancy
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 |
|---|---|---|
| disconnection techniqueBefore lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker. | Other | BB(Bronchial Blocker) group, DLT(Double Lumen Tube) group |
Primary outcome
Lung deflation score
Time frame: 10 min after inflation of balloon
verbal analog scale(0=no deflation, 10=complete deflation)
2 secondary outcomes
time for initial placement
Time frame: from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
time for lung deflation
Time frame: from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
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 6 Nov 2018.
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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.
Go Un Roh, MD principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing disconnection technique in people with Pneumothorax, run by Ajou University School of Medicine.
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 6 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 6 Nov 2018. 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. 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?
Lung deflation score (time frame: 10 min after inflation of balloon). 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 6 Nov 2018.