PneumothoraxNCT01846936
Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation
A study testing DLT with conventional technique, BB with conventional technique and Disconnection technique in people with Pneumothorax, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- DLT with conventional technique, BB with conventional technique and Disconnection technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing thoracic surgery for which OLV is required
Who cannot join
- Patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Trial Comparing Double-lumen Tube and Bronchial Blocker With or Without Modified Disconnection Technique
One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique.
Read the detailed description
In selecting this maneuver of OLV, lung collapse is a major concern because it permits adequate surgical exposure. Although once lung deflation was achieved, the overall clinical performance appears to be similar, BB takes longer to deflate the operative lung and there is some conflict reports as to BB provides a similar degree of lung deflation compared to that of DLT.
The aim of this study was to compare the efficacy of BB and DLT for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in BB. The investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.
- Conditions
- Pneumothorax
- Being tested
- DLT with conventional technique, BB with conventional technique, Disconnection technique
- Keywords
- one lung ventilation, efficacy, bronchial blocker
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLT with conventional techniqueProcedure or surgery
The double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered.
BB with conventional techniqueProcedure or surgery
The brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under FOB vision by turning the device's steering wheel.
The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation.
Disconnection techniqueProcedure or surgery
Disconnection technique 1) deflate of the blocker cuff, 2) turn-off the ventilator and opened the APL valve allowing both lungs to collapse, 3) after loss of carbon dioxide trace in the capnograph, reinflate blocker cuff with the same volume of air as during the initial insertion, 4) reconnect the tube to the ventilator allowing only dependent-lung reventilation with a 5 cmH2O positive end-expiratory pressure preceded by a single recruitment maneuver performed by elevating the airway pressure to 40 cmH2O for 7 seconds.
| Study group | Role | What they receive |
|---|---|---|
| DLT with conventional technique | Experimental | The double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered.
One lung ventilation is initiated after the lumen of operative lung is clamped and opened. Receives: Procedure: DLT with conventional technique |
| BB with conventional technique | Active comparator | The brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under fiberoptic bronchoscopy (FOB) vision by turning the device's steering wheel.
The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation. And then, dependent lung is ventilated. Receives: Procedure: BB with conventional technique |
| Disconnection technique | Active comparator | Disconnection technique; 1) before initiating OLV, we turned-off the ventilator and fully opened the adjustable pressure limiting valve allowing both lungs to collapse, and 2) after loss of the carbon dioxide trace on the capnograph, 3) inflated the BB cuff with air, and 4) turned-on the ventilator allowing only dependent-lung reventilation. Receives: Procedure: Disconnection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of three lung isolation methods
The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.
Measured: Five min from the start of one lung ventilation
Effectiveness of three lung isolation methods
The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.
Measured: Ten min from the start of one lung ventilation
Secondary outcomes (1)
The disconnection time
Before initiating OLV in group 3, we turned-off the ventilator and fully opened the adjustable pressure limiting valve allowing both lungs to collapse. And then, the time which capnograph lose the carbon dioxide curve is considered the disconnection time required for both lungs to collapse before initiating one lung ventilation.
Measured: The time to loss the carbon dioxide trace on the capnograph (30 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Park, Ajou University School of Medicine
- Investigators
- Sung Yong Park, MD, Principal investigator, Ajou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846936
- Sponsor's protocol ID
- AJIRB-DEV-DE1012-001
- Status last verified
- Jun 2015
- First submitted
- 24 Oct 2012
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial Comparing Double-lumen Tube and Bronchial Blocker With or Without Modified Disconnection Technique
- ClinicalTrials.gov ID
- NCT01846936
- Acronym / sponsor ID
- AJIRB-DEV-DE1012-001
- Conditions
- Pneumothorax
- Keywords
- one lung ventilation, efficacy, bronchial blocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 May 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.
One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique.
Detailed description
In selecting this maneuver of OLV, lung collapse is a major concern because it permits adequate surgical exposure. Although once lung deflation was achieved, the overall clinical performance appears to be similar, BB takes longer to deflate the operative lung and there is some conflict reports as to BB provides a similar degree of lung deflation compared to that of DLT.
The aim of this study was to compare the efficacy of BB and DLT for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in BB. The investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLT with conventional technique | Experimental | Procedure: DLT with conventional techniqueThe double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered. One lung ventilation is initiated after the lumen of operative lung is clamped and opened. |
| BB with conventional technique | Active comparator | Procedure: BB with conventional techniqueThe brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under fiberoptic bronchoscopy (FOB) vision by turning the device's steering wheel. The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation. And then, dependent lung is ventilated. |
| Disconnection technique | Active comparator | Procedure: Disconnection techniqueDisconnection technique; 1) before initiating OLV, we turned-off the ventilator and fully opened the adjustable pressure limiting valve allowing both lungs to collapse, and 2) after loss of the carbon dioxide trace on the capnograph, 3) inflated the BB cuff with air, and 4) turned-on the ventilator allowing only dependent-lung reventilation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery for which OLV is required
Key exclusion criteria (1 listed)
- Patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.
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 |
|---|---|---|
| DLT with conventional techniqueThe double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered. | Procedure or surgery | DLT with conventional technique |
| BB with conventional techniqueThe brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under FOB vision by turning the device's steering wheel. The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation. | Procedure or surgery | BB with conventional technique |
| Disconnection techniqueDisconnection technique 1) deflate of the blocker cuff, 2) turn-off the ventilator and opened the APL valve allowing both lungs to collapse, 3) after loss of carbon dioxide trace in the capnograph, reinflate blocker cuff with the same volume of air as during the initial insertion, 4) reconnect the tube to the ventilator allowing only dependent-lung reventilation with a 5 cmH2O positive end-expiratory pressure preceded by a single recruitment maneuver performed by elevating the airway pressure to 40 cmH2O for 7 seconds. | Procedure or surgery | Disconnection technique |
Primary outcome
Effectiveness of three lung isolation methods
Time frame: Five min from the start of one lung ventilation
The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.
Effectiveness of three lung isolation methods
Time frame: Ten min from the start of one lung ventilation
The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.
1 secondary outcome
The disconnection time
Time frame: The time to loss the carbon dioxide trace on the capnograph (30 seconds)
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 24 Jun 2015.
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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.
Sung Yong Park, MD principal investigator
Ajou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLT with conventional technique, BB with conventional technique and Disconnection technique in people with Pneumothorax, run by Ajou University School of Medicine 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 1 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: finished, as of the sponsor's last update on 24 Jun 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?
Effectiveness of three lung isolation methods (time frame: Five min from the start of one lung ventilation). 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?
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 24 Jun 2015.