Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During SurgeryPhase 4NCT01807676
Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
A Phase 4 study testing ET View Double Lumen Tube and conventional Double Lumen Tube in people with Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery, run by University of Zurich at 1 site in Switzerland.
Trial summary
No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT. Trial with medical device Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery
- What is being tested?
- ET View Double Lumen Tube and conventional Double Lumen Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Mar 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective thoracic surgery with anticipated use of a DLT
- Anticipated extubation in the operating room;
- American Society of Anesthesiologist Physical Status 1-3;
- Age 18- 90.
- Written consent (signature from patient)
Who cannot join
- Tracheal pathology, including tracheostomy;
- Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
- BMI higher exceeding 40 kg/m2;
- Known or suspected difficult airway.
- Pregnancy
- Breast feeding
- The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.
- Trial with medical device
Read the detailed description
In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.
The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.
The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.
The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.
- Being tested
- ET View Double Lumen Tube, conventional Double Lumen Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET View Double Lumen TubeDevice
Also called VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel)
conventional Double Lumen TubeDevice
Also called conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany)
| Study group | Role | What they receive |
|---|---|---|
| ET View Double Lumen Tube | Active comparator | Patients assigned to the thisgroup will be intubated using the VivaSight-DL. Receives: Device: ET View Double Lumen Tube |
| conventional Double Lumen Tube | Active comparator | Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany). Receives: Device: conventional Double Lumen Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch.
Measured: 300 seconds
Secondary outcomes (9)
Rate of misplacement
Rate of misplacement, occurring after patients removal from dorsal to lateral position
Measured: 3 hours
Rate of misplacement
Rate of misplacement, occurring during surgery, potentially caused by vibrations and movements by surgeons
Measured: 3 hours
Rate of blind insertion
Rate of blind insertion, defined as successful placement of airway device in correct position in trachea/ main stream bronchus without help of fibreoptic bronchoscopy8
Measured: 300 seconds
rate of fibreoptic bronchoscopy
Necessity of tube re-placement by fibreoptic bronchoscopy
Measured: 3 hours
Quality of lung collapse
Measured: 3 hours
Airway injuries
Measured: 3 hours
Postoperative coughing
Measured: 24 hours
Postoperative hoarseness
Measured: 24 hours
Postoperative sore throat
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionMar 2014
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 Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During SurgeryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Beck Schimmer, Prof MD, Principal investigator, University Hospital Zurich, Division of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807676
- Sponsor's protocol ID
- 2012-0520
- Status last verified
- Apr 2014
- First submitted
- 7 Mar 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
Publications
Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6.
PubMed 25663254
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
- ClinicalTrials.gov ID
- NCT01807676
- Acronym / sponsor ID
- 2012-0520
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Mar 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.
No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.
- Trial with medical device
Detailed description
In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.
The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.
The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.
The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET View Double Lumen Tube | Active comparator | Device: ET View Double Lumen TubePatients assigned to the thisgroup will be intubated using the VivaSight-DL. |
| conventional Double Lumen Tube | Active comparator | Device: conventional Double Lumen TubePatients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective thoracic surgery with anticipated use of a DLT
- Anticipated extubation in the operating room;
- American Society of Anesthesiologist Physical Status 1-3;
- Age 18- 90.
- Written consent (signature from patient)
Key exclusion criteria (7 listed)
- Tracheal pathology, including tracheostomy;
- Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
- BMI higher exceeding 40 kg/m2;
- Known or suspected difficult airway.
- 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 |
|---|---|---|
| ET View Double Lumen TubeAlso: VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) | Device | ET View Double Lumen Tube |
| conventional Double Lumen TubeAlso: conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany) | Device | conventional Double Lumen Tube |
Primary outcome
time to intubation
Time frame: 300 seconds
Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch.
9 secondary outcomes
Rate of misplacement
Time frame: 3 hours
Rate of misplacement
Time frame: 3 hours
Rate of blind insertion
Time frame: 300 seconds
rate of fibreoptic bronchoscopy
Time frame: 3 hours
Quality of lung collapse
Time frame: 3 hours
Airway injuries
Time frame: 3 hours
Postoperative coughing
Time frame: 24 hours
Postoperative hoarseness
Time frame: 24 hours
Postoperative sore throat
Time frame: 24 hours
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 28 Apr 2014.
- Derived from this study: PubMed 25663254Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6.
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.
Beatrice Beck Schimmer, Prof MD principal investigator
University Hospital Zurich, Division of Anaesthesiology
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 ET View Double Lumen Tube and conventional Double Lumen Tube in people with Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery, run by University of Zurich at 1 site in Switzerland.
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 5 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 28 Apr 2014. 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 Switzerland. 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?
time to intubation (time frame: 300 seconds). 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 NCT01807676, 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 28 Apr 2014.