One-lung VentilationPhase 4NCT01073722
EZ Blocker Versus Left Sided Double-lumen Tube
A Phase 4 study testing Placement of double lumen tube for one-lung ventilation and Placement of EZ- Blocker for one-lung ventilation in people with One-lung Ventilation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-lung Ventilation
- What is being tested?
- Placement of double lumen tube for one-lung ventilation and Placement of EZ- Blocker for one-lung ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Apr 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3 patients
- Patients scheduled for surgery requiring a left sided DLT for single lung ventilation
Who cannot join
- Contraindications are lesions along the path of the left sided double lumen tube or the EZB
- Tracheal or mainstem bronchial stenosis
- Distorted carinal anatomy,
- Anticipated difficult intubation (Mallampatti score ≥ 3)
- History or presence of tracheostoma
- Patients who require absolute lung separation
- Patients who require sleeve resection of mainstem bronchus
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Anesthesiology, Pain and Palliative Medicine of the Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
About this study
Official title: Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation
Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes difficult or even impossible to introduce. The DLT is larger than a conventional single lumen tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to the DLT, bronchial blocking devices are more difficult to position and need more frequent intraoperative repositioning. These disadvantages of the existing devices for lung isolation prompted further development of the bronchial blocker concept. The design of a new Y shaped bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB), combines the advantages of both lung isolation techniques. The aim of the study is to compare in a randomised, prospective way the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the EZB is a target of the study.
- Conditions
- One-lung Ventilation
- Being tested
- Placement of double lumen tube for one-lung ventilation, Placement of EZ- Blocker for one-lung ventilation
- Keywords
- thoracic surgery, one-lung ventilation, double lumen tube, endobronchial blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of double lumen tube for one-lung ventilationDevice
Also called Broncho-cath (Mallinckrodt)
The gold standard for lung isolation is the use of a double lumen tube (DLT). A DLT is a bifurcated tube with a bronchial and a tracheal lumen.
Placement of EZ- Blocker for one-lung ventilationDevice
Also called EZ-blocker (AnaesthetIQ BV, Rotterdam, The Netherlands)
Bronchial blockers are balloon-tipped semi-rigid catheters. Different types are available. They are not easy to put in position and frequently dislocates during repositioning of the patient or during surgical manipulation. To solve these problems, a novel type of bronchus blocker, i.e. the EZ- Blocker® is developed. The EZB is also a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. These improvements owe to the fact that the blocker anchors itself on the carina with the two extensions.
| Study group | Role | What they receive |
|---|---|---|
| Left double lumen tube | Active comparator | Traditionally, single lung ventilation is obtained with a double lumen tube (DLT). In our institution a polyvinyl DLT (Broncho-cath, Mallinckrodt,) without carinal hook, is used. This type of tube exists of a tube with two lumen with two distal cuffs. One lumen (called the bronchial lumen) extends some distance further, has a slight curvature and has a small blue cuff. The other lumen (called the tracheal lumen) has a larger cuff. A DLT tube exists in four sizes and one can choose in a left or a right configuration. Almost always, we use a left sided DLT. A DLT has a much larger diameter than a standard single lumen endotracheal tube Receives: Device: Placement of double lumen tube for one-lung ventilation |
| EZ-blocker | Active comparator | The EZ-blocker (EZB) is a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. It is intended for use in combination with a standard single lumen tube. After the EZB is advanced trough the distal end of the single lumen tube, both extensions spread out and find their way in the left and right main stem bronchi. The place where the two extensions are attached to the shaft now rests on the carina. Fiber optic bronchoscopy should be used for proper positioning. After placement of the EZB, one of the cuffs can be inflated to obtain lung separation under direct visual inspection with fiber optic bronchoscopy. Receives: Device: Placement of EZ- Blocker for one-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of malposition of a left sided DLT or the EZB
Measured: there are four time points (after insertion of the device, after inflation of cuff or balloon, after repositioning patient, during surgery) were malposition are considered. Total time spend is 3 hours on the day of the operation
Secondary outcomes (3)
description of damage to laryngeal, tracheal and bronchial structures
Measured: videobronchoscopy before and after intervention. Time frame 5 min for each video and additional 5 min for assessment afterwards on the day of the operation
the ease of insertion
Measured: the ease of insertion of the devices is qualitative variable: 1= excellent, 2= good, 3=average, 4=poor. Time frame is 5 min on the day of the operation.
the incidence of postoperative complains of sore throat and hoarseness
Measured: questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-lung VentilationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jo Mourisse, Dr., Principal investigator, Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073722
- Sponsor's protocol ID
- NL30799,091,09
- Status last verified
- Aug 2010
- First submitted
- 17 Feb 2010
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation
- ClinicalTrials.gov ID
- NCT01073722
- Acronym / sponsor ID
- NL30799,091,09
- Conditions
- One-lung Ventilation
- Keywords
- thoracic surgery, one-lung ventilation, double lumen tube, endobronchial blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Feb 2010 (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 is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes difficult or even impossible to introduce. The DLT is larger than a conventional single lumen tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to the DLT, bronchial blocking devices are more difficult to position and need more frequent intraoperative repositioning. These disadvantages of the existing devices for lung isolation prompted further development of the bronchial blocker concept. The design of a new Y shaped bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB), combines the advantages of both lung isolation techniques. The aim of the study is to compare in a randomised, prospective way the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the EZB is a target of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left double lumen tube | Active comparator | Device: Placement of double lumen tube for one-lung ventilationTraditionally, single lung ventilation is obtained with a double lumen tube (DLT). In our institution a polyvinyl DLT (Broncho-cath, Mallinckrodt,) without carinal hook, is used. This type of tube exists of a tube with two lumen with two distal cuffs. One lumen (called the bronchial lumen) extends some distance further, has a slight curvature and has a small blue cuff. The other lumen (called the tracheal lumen) has a larger cuff. A DLT tube exists in four sizes and one can choose in a left or a right configuration. Almost always, we use a left sided DLT. A DLT has a much larger diameter than a standard single lumen endotracheal tube |
| EZ-blocker | Active comparator | Device: Placement of EZ- Blocker for one-lung ventilationThe EZ-blocker (EZB) is a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. It is intended for use in combination with a standard single lumen tube. After the EZB is advanced trough the distal end of the single lumen tube, both extensions spread out and find their way in the left and right main stem bronchi. The place where the two extensions are attached to the shaft now rests on the carina. Fiber optic bronchoscopy should be used for proper positioning. After placement of the EZB, one of the cuffs can be inflated to obtain lung separation under direct visual inspection with fiber optic bronchoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status 1-3 patients
- Patients scheduled for surgery requiring a left sided DLT for single lung ventilation
Key exclusion criteria (7 listed)
- Contraindications are lesions along the path of the left sided double lumen tube or the EZB
- Tracheal or mainstem bronchial stenosis
- Distorted carinal anatomy,
- Anticipated difficult intubation (Mallampatti score ≥ 3)
- History or presence of tracheostoma
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 |
|---|---|---|
| Placement of double lumen tube for one-lung ventilationAlso: Broncho-cath (Mallinckrodt)The gold standard for lung isolation is the use of a double lumen tube (DLT). A DLT is a bifurcated tube with a bronchial and a tracheal lumen. | Device | Left double lumen tube |
| Placement of EZ- Blocker for one-lung ventilationAlso: EZ-blocker (AnaesthetIQ BV, Rotterdam, The Netherlands)Bronchial blockers are balloon-tipped semi-rigid catheters. Different types are available. They are not easy to put in position and frequently dislocates during repositioning of the patient or during surgical manipulation. To solve these problems, a novel type of bronchus blocker, i.e. the EZ- Blocker® is developed. The EZB is also a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. These improvements owe to the fact that the blocker anchors itself on the carina with the two extensions. | Device | EZ-blocker |
Primary outcome
the incidence of malposition of a left sided DLT or the EZB
Time frame: there are four time points (after insertion of the device, after inflation of cuff or balloon, after repositioning patient, during surgery) were malposition are considered. Total time spend is 3 hours on the day of the operation
3 secondary outcomes
description of damage to laryngeal, tracheal and bronchial structures
Time frame: videobronchoscopy before and after intervention. Time frame 5 min for each video and additional 5 min for assessment afterwards on the day of the operation
the ease of insertion
Time frame: the ease of insertion of the devices is qualitative variable: 1= excellent, 2= good, 3=average, 4=poor. Time frame is 5 min on the day of the operation.
the incidence of postoperative complains of sore throat and hoarseness
Time frame: questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery
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 2 May 2011.
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Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
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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.
Jo Mourisse, Dr. principal investigator
Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Placement of double lumen tube for one-lung ventilation and Placement of EZ- Blocker for one-lung ventilation in people with One-lung Ventilation, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 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 2 May 2011. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the incidence of malposition of a left sided DLT or the EZB (time frame: there are four time points (after insertion of the device, after inflation of cuff or balloon, after repositioning patient, during surgery) were malposition are considered. Total time spend is 3 hours on the day of the operation). 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 2 May 2011; AzTrials last refreshed its copy on 1 Nov 2026.