Lung Separation TechniquesPhase 4NCT02912598
Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices
A Phase 4 study testing Mallinckrodt™ Endobronchial Tube, Fuji Uniblocker™ and ETView VivaSight™-SL+EB in people with Lung Separation Techniques and One-Lung Ventilation, run by Otto-von-Guericke University Magdeburg.
Trial summary
Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Separation Techniques, One-Lung Ventilation
- What is being tested?
- Mallinckrodt™ Endobronchial Tube, Fuji Uniblocker™ and ETView VivaSight™-SL+EB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2015
- 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
- age greater than or at 18 years
- scheduled for elective thoracic surgery with one-lung ventilation
- written informed consent in anaesthesia, the study and anonymized data collection
Who cannot join
- necessary conversion between devices
- one-lung ventilation impossible to establish
- denial of the study or data collection
- surgical or anatomical circumstances preventing the use of a double-lumen tube
About this study
Official title: Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices
Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.
- Conditions
- Lung Separation Techniques, One-Lung Ventilation
- Being tested
- Mallinckrodt™ Endobronchial Tube, Fuji Uniblocker™, ETView VivaSight™-SL+EB, COOK© Arndt Endobronchial Blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallinckrodt™ Endobronchial TubeDevice
Fuji Uniblocker™Device
ETView VivaSight™-SL+EBDevice
COOK© Arndt Endobronchial BlockerDevice
| Study group | Role | What they receive |
|---|---|---|
| Mallinckrodt™ Endobronchial Tube | Active comparator | Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation. Receives: Device: Mallinckrodt™ Endobronchial Tube |
| Fuji Uniblocker™ | Active comparator | Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation. Receives: Device: Fuji Uniblocker™ |
| ETView VivaSight™-SL+EB | Experimental | Usage of a ETView VivaSight™-EB endobronchial blocker in a ETView VivaSight™-SL single-lumen tube to achieve lung isolation and one lung ventilation. Receives: Device: ETView VivaSight™-SL+EB |
| COOK© Arndt Endobronchial Blocker | Active comparator | Usage of a COOK© Arndt Endobronchial Blocker in a generic single-lumen tube to achieve lung isolation and one lung ventilation. Receives: Device: COOK© Arndt Endobronchial Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initial lung isolation
Duration of initial bronchoscopy-guided placement of the endobronchial ballon. Start: Beginning of direct laryngoscopy. End: Initial inflation of the endobronchially placed cuff.
Measured: intraoperative
Secondary outcomes (5)
Ease of placement [numerical rating scale]
Evaluation of difficulty of endobronchial device placement by the anaesthetist.
Measured: intraoperative
Rate of dislocation
Number of device dislocations after correct initial placement. Measurement time point after termination of one-lung ventilation.
Measured: intraoperative
Quality of surgical exposure [numerical rating scale]
Surgeon's grading of the quality of surgical exposure resulting from lung deflation. Time point is initial view of the thoracic cavity after pleural incision.
Measured: intraoperative
Oxygenation
Measurement of arterial partial pressure of oxygen by blood gas analysis taken 5min and 15min after establishment of one-lung ventilation.
Measured: intraoperative
Bronchoscopies
Number of additional bronchoscopies required after initial placement resulting from suspected or actual dislocations.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Separation TechniquesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Kreft, Otto-von-Guericke University Magdeburg
- Investigators
- Thomas Hachenberg, Prof. Dr. med., Study chair, Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912598
- Sponsor's protocol ID
- 142/14
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices
- ClinicalTrials.gov ID
- NCT02912598
- Acronym / sponsor ID
- 142/14
- Conditions
- Lung Separation Techniques, One-Lung Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Sep 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.
Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mallinckrodt™ Endobronchial Tube | Active comparator | Device: Mallinckrodt™ Endobronchial TubeUsage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation. |
| Fuji Uniblocker™ | Active comparator | Device: Fuji Uniblocker™Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation. |
| ETView VivaSight™-SL+EB | Experimental | Device: ETView VivaSight™-SL+EBUsage of a ETView VivaSight™-EB endobronchial blocker in a ETView VivaSight™-SL single-lumen tube to achieve lung isolation and one lung ventilation. |
| COOK© Arndt Endobronchial Blocker | Active comparator | Device: COOK© Arndt Endobronchial BlockerUsage of a COOK© Arndt Endobronchial Blocker in a generic single-lumen tube to achieve lung isolation and one lung ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than or at 18 years
- scheduled for elective thoracic surgery with one-lung ventilation
- written informed consent in anaesthesia, the study and anonymized data collection
Key exclusion criteria (4 listed)
- necessary conversion between devices
- one-lung ventilation impossible to establish
- denial of the study or data collection
- surgical or anatomical circumstances preventing the use of a double-lumen tube
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 |
|---|---|---|
| Mallinckrodt™ Endobronchial Tube | Device | Mallinckrodt™ Endobronchial Tube |
| Fuji Uniblocker™ | Device | Fuji Uniblocker™ |
| ETView VivaSight™-SL+EB | Device | ETView VivaSight™-SL+EB |
| COOK© Arndt Endobronchial Blocker | Device | COOK© Arndt Endobronchial Blocker |
Primary outcome
Time to initial lung isolation
Time frame: intraoperative
Duration of initial bronchoscopy-guided placement of the endobronchial ballon. Start: Beginning of direct laryngoscopy. End: Initial inflation of the endobronchially placed cuff.
5 secondary outcomes
Ease of placement [numerical rating scale]
Time frame: intraoperative
Rate of dislocation
Time frame: intraoperative
Quality of surgical exposure [numerical rating scale]
Time frame: intraoperative
Oxygenation
Time frame: intraoperative
Bronchoscopies
Time frame: intraoperative
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 23 Sep 2016.
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.
Thomas Hachenberg, Prof. Dr. med. study chair
Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mallinckrodt™ Endobronchial Tube, Fuji Uniblocker™ and ETView VivaSight™-SL+EB in people with Lung Separation Techniques and One-Lung Ventilation, run by Otto-von-Guericke University Magdeburg.
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 4 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 23 Sep 2016. 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.
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?
Time to initial lung isolation (time frame: intraoperative). 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 23 Sep 2016.