Endotracheal IntubationPhase 4NCT02253979
Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube
A Phase 4 study testing Standard double lumen tube and VivaSight double lumen tube in people with Endotracheal Intubation and Airway Management, run by Rambam Health Care Campus.
Trial summary
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation, Airway Management, One Lung Ventilation
- What is being tested?
- Standard double lumen tube and VivaSight double lumen tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing video assisted thoracoscopic lung lobectomy
Who cannot join
- anticipated difficult intubation, patients who required rapid sequence induction
- patients with known tracheal pathology
About this study
Official title: Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.
Read the detailed description
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.
- Being tested
- Standard double lumen tube, VivaSight double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard double lumen tubeDevice
Endotracheal left side double lumen tube
VivaSight double lumen tubeDevice
VivaSight double lumen endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| standard double lumen tube | Placebo comparator | Intervention: Standard double lumen tube Receives: Device: Standard double lumen tube |
| VivaSight double lumen tube | Experimental | Intervention: VivaSight double lumen tube Receives: Device: VivaSight double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for endotracheal intubation with visual confirmation of double lumen tube position position.
Measured: During induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies 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
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Levy-Faber, Dr., Principal investigator, Senior Surgeon, Department of Cardio-Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253979
- Sponsor's protocol ID
- 0334-12-RMB_CTIL
- Status last verified
- Sep 2014
- First submitted
- 28 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.
PubMed 24656617Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.
PubMed 14722168Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
PubMed 9477054
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02253979
- Acronym / sponsor ID
- 0334-12-RMB_CTIL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Oct 2014 (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.
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.
Detailed description
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard double lumen tube | Placebo comparator | Device: Standard double lumen tubeIntervention: Standard double lumen tube |
| VivaSight double lumen tube | Experimental | Device: VivaSight double lumen tubeIntervention: VivaSight double lumen tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing video assisted thoracoscopic lung lobectomy
Key exclusion criteria (2 listed)
- anticipated difficult intubation, patients who required rapid sequence induction
- patients with known tracheal pathology
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 |
|---|---|---|
| Standard double lumen tubeEndotracheal left side double lumen tube | Device | standard double lumen tube |
| VivaSight double lumen tubeVivaSight double lumen endotracheal intubation | Device | VivaSight double lumen tube |
Primary outcome
Time required for endotracheal intubation with visual confirmation of double lumen tube position position.
Time frame: During induction of general anesthesia
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 1 Oct 2014.
- Results publication: PubMed 24656617Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.
- Results publication: PubMed 14722168Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.
- Results publication: PubMed 9477054Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
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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.
Dan Levy-Faber, Dr. principal investigator
Senior Surgeon, Department of Cardio-Thoracic Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard double lumen tube and VivaSight double lumen tube in people with Endotracheal Intubation and Airway Management, run by Rambam Health Care Campus.
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 2 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 1 Oct 2014. 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. Some participants in this study may receive a placebo. 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 required for endotracheal intubation with visual confirmation of double lumen tube position position. (time frame: During induction of general anesthesia). 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 NCT02253979, which also lists 3 linked publications.
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 1 Oct 2014.