Intubation, IntratrachealNCT03665896
VivaSight Left-sided Double Lumen Tube Study
A study testing intubation with VivaSight double-lumen tube, intubation with standard double-lumen tube and fiberoptic bronchoscopy in people with Intubation, Intratracheal, run by Javier H Campos.
Trial summary
The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- intubation with VivaSight double-lumen tube, intubation with standard double-lumen tube and fiberoptic bronchoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2013to 21 Mar 2014
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement
Who cannot join
- More than 90 years of age
- Patients with emergency surgery
- Prisoners
- Patient who cannot provide their own consent
- Patient refusal
- Non-English speaking patients
About this study
Official title: A Comparison of Placement With the VivaSight Left-sided Double Lumen Tube With an Integrated Monitor/Camera Versus the Standard Left-sided Double Lumen Tube (DLT) With Fiberoptic Bronchoscopy in Patients Requiring One-lung Ventilation (OLV)
The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.
The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.
Read the detailed description
The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.
The investigators will compare the intubation time for the VivaSight™-DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.
The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.
- Conditions
- Intubation, Intratracheal
- Being tested
- intubation with VivaSight double-lumen tube, intubation with standard double-lumen tube, fiberoptic bronchoscopy
- Keywords
- double-lumen endotracheal tube, VivaSight double-lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation with VivaSight double-lumen tubeDevice
intubation with standard double-lumen tubeDevice
fiberoptic bronchoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VivaSight DLT group | Active comparator | Thoracic surgery patient is intubated with VivaSight double-lumen tube (intubation with VivaSight double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera, is recorded. The tube position is reconfirmed by fiberoptic bronchoscopy. Receives: Device: intubation with VivaSight double-lumen tube; Procedure: fiberoptic bronchoscopy |
| Standard DLT group | Placebo comparator | Thoracic surgery patient is intubated with standard double-lumen tube (intubation with standard double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by fiberoptic bronchoscopy, is recorded. Receives: Device: intubation with standard double-lumen tube; Procedure: fiberoptic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.
Measured: Within 5 minutes
Secondary outcomes (1)
Picture reliability of the embedded camera of VivaSight double-lumen tube
Picture reliability of the embedded camera will be assessed based upon the proper identification of the following structures; a) Carina, b) Left bronchial cuff , c) A radiopaque line of left bronchial tube, d) Right main bronchus.
Measured: Within 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start10 Jul 2013
- Primary completion21 Mar 2014
- Study completion21 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier H Campos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier H Campos, University of Iowa
- Investigators
- Javier H Campos, MD, Principal investigator, University of Iowa Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665896
- Sponsor's protocol ID
- 201302811
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Placement With the VivaSight Left-sided Double Lumen Tube With an Integrated Monitor/Camera Versus the Standard Left-sided Double Lumen Tube (DLT) With Fiberoptic Bronchoscopy in Patients Requiring One-lung Ventilation (OLV)
- ClinicalTrials.gov ID
- NCT03665896
- Acronym / sponsor ID
- 201302811
- Conditions
- Intubation, Intratracheal
- Keywords
- double-lumen endotracheal tube, VivaSight double-lumen tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Javier H CamposUniversity, hospital or other
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 21 Mar 2014 (actual)
- Study completion
- 21 Mar 2014 (actual)
- First posted
- 11 Sep 2018 (actual)
- 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.
The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.
The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.
Detailed description
The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.
The investigators will compare the intubation time for the VivaSight™-DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.
The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VivaSight DLT group | Active comparator | Device: intubation with VivaSight double-lumen tube, Procedure: fiberoptic bronchoscopyThoracic surgery patient is intubated with VivaSight double-lumen tube (intubation with VivaSight double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera, is recorded. The tube position is reconfirmed by fiberoptic bronchoscopy. |
| Standard DLT group | Placebo comparator | Device: intubation with standard double-lumen tube, Procedure: fiberoptic bronchoscopyThoracic surgery patient is intubated with standard double-lumen tube (intubation with standard double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by fiberoptic bronchoscopy, is recorded. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement
Key exclusion criteria (6 listed)
- More than 90 years of age
- Patients with emergency surgery
- Prisoners
- Patient who cannot provide their own consent
- Patient refusal
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 |
|---|---|---|
| intubation with VivaSight double-lumen tube | Device | VivaSight DLT group |
| intubation with standard double-lumen tube | Device | Standard DLT group |
| fiberoptic bronchoscopy | Procedure or surgery | Standard DLT group, VivaSight DLT group |
Primary outcome
Intubation time
Time frame: Within 5 minutes
We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.
1 secondary outcome
Picture reliability of the embedded camera of VivaSight double-lumen tube
Time frame: Within 10 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 11 Sep 2018.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Related trials for Intubation, Intratracheal
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
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.
Javier H Campos, MD principal investigator
University of Iowa Hospitals & Clinics
Questions about this trial
What is this clinical trial studying?
A study testing intubation with VivaSight double-lumen tube, intubation with standard double-lumen tube and fiberoptic bronchoscopy in people with Intubation, Intratracheal, run by Javier H Campos.
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 6 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 11 Sep 2018. 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.
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?
Intubation time (time frame: Within 5 minutes). 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 11 Sep 2018.