Performance and Safety of an Airway Management DeviceNCT01757977
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
A study testing double lumen endotracheal tube placement and use in people with Performance and Safety of an Airway Management Device, run by John Laffey at 1 site in Ireland.
Trial summary
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Performance and Safety of an Airway Management Device
- What is being tested?
- double lumen endotracheal tube placement and use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2012to Jan 2013
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 - 85 yr old patients capable of informed consent
- ASA (American Society of Anesthesiologists physical status) 1-3
- non-emergency surgery of expected duration < 6 hours
- one-lung ventilation required
Who cannot join
- BMI > 35
- expected difficult airway
- Mallampati score >2
- increased risk of aspiration
- upper airway or upper GI problems
- live pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.
Read the detailed description
Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position.
A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position.
This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
Standard anesthetic preassessment and anesthesia will be provided.
Consenting patients passing the inclusion and exclusion criteria will be randomly allocated to either of the 2 study groups.
Protocol for attempts at placement and tube position confirmation will be followed.
The investigators will monitor a number of parameters, including time and ease of tube insertion, ability to verify tube position with the primary imaging modality for each group, need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope during the case, quality of lung collapse, problems with ventilation and other.
The primary hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.
- Being tested
- double lumen endotracheal tube placement and use
- Keywords
- Vivasight DL, double lumen endotracheal tube, fiberoptic confirmation of tube position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double lumen endotracheal tube placement and useDevice
| Study group | Role | What they receive |
|---|---|---|
| Vivasight DL | Experimental | placement and intraoperative use of Vivasight DL double lumen endobronchial tube Receives: Device: double lumen endotracheal tube placement and use |
| standard DLT | Active comparator | placement and intraoperative use of a standard double lumen endotracheal tube. Receives: Device: double lumen endotracheal tube placement and use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of optical view obtained to confirm optimal tube position.
The hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.
Measured: within 60 minutes of commencement of general anesthesia
Secondary outcomes (6)
Time to confirmation of tube position
Measured: within 60 minutes of commencement of general anesthesia
Operator rated Device Difficulty Score
The investigators will use 10cm visual analogue scale (VAS) to rate the overall ease of device use till successful placement achieved and position confirmed optically.
Measured: within 60 minutes of commencement of general anesthesia
Time from initial laryngoscopy to passing tube through vocal cords
Measured: Within 60 minutes of commencement of general anesthesia
rate of malposition
the investigators will record the number/type of tube position adjustment maneuvers
Measured: within 15 hours of commencement of general anesthesia
need to pass a fiberoptic bronchoscope during case
Measured: within 15 hours of commencement of general anesthesia
presence of blood at the carina immediately post intubation
Measured: within 60 minutes of commencement 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 posted31 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance and Safety of an Airway Management DeviceStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Laffey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Laffey, University College Hospital Galway
- Investigators
- Brian Harte, FFARCSI, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757977
- Sponsor's protocol ID
- C.A.751
- Status last verified
- Mar 2013
- First submitted
- 22 Dec 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01757977
- Acronym / sponsor ID
- C.A.751
- Keywords
- Vivasight DL, double lumen endotracheal tube, fiberoptic confirmation of tube position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- John LaffeyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Dec 2012 (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.
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.
Detailed description
Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position.
A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position.
This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
Standard anesthetic preassessment and anesthesia will be provided.
Consenting patients passing the inclusion and exclusion criteria will be randomly allocated to either of the 2 study groups.
Protocol for attempts at placement and tube position confirmation will be followed.
The investigators will monitor a number of parameters, including time and ease of tube insertion, ability to verify tube position with the primary imaging modality for each group, need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope during the case, quality of lung collapse, problems with ventilation and other.
The primary hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivasight DL | Experimental | Device: double lumen endotracheal tube placement and useplacement and intraoperative use of Vivasight DL double lumen endobronchial tube |
| standard DLT | Active comparator | Device: double lumen endotracheal tube placement and useplacement and intraoperative use of a standard double lumen endotracheal tube. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 16 - 85 yr old patients capable of informed consent
- ASA (American Society of Anesthesiologists physical status) 1-3
- non-emergency surgery of expected duration < 6 hours
- one-lung ventilation required
Key exclusion criteria (6 listed)
- BMI > 35
- expected difficult airway
- Mallampati score >2
- increased risk of aspiration
- upper airway or upper GI problems
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 |
|---|---|---|
| double lumen endotracheal tube placement and use | Device | Vivasight DL, standard DLT |
Primary outcome
Adequacy of optical view obtained to confirm optimal tube position.
Time frame: within 60 minutes of commencement of general anesthesia
The hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.
6 secondary outcomes
Time to confirmation of tube position
Time frame: within 60 minutes of commencement of general anesthesia
Operator rated Device Difficulty Score
Time frame: within 60 minutes of commencement of general anesthesia
Time from initial laryngoscopy to passing tube through vocal cords
Time frame: Within 60 minutes of commencement of general anesthesia
rate of malposition
Time frame: within 15 hours of commencement of general anesthesia
need to pass a fiberoptic bronchoscope during case
Time frame: within 15 hours of commencement of general anesthesia
presence of blood at the carina immediately post intubation
Time frame: within 60 minutes of commencement 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 19 Mar 2013.
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.
Brian Harte, FFARCSI principal investigator
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double lumen endotracheal tube placement and use in people with Performance and Safety of an Airway Management Device, run by John Laffey at 1 site in Ireland.
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 4 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 19 Mar 2013. 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 Ireland. 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.
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?
Adequacy of optical view obtained to confirm optimal tube position. (time frame: within 60 minutes of commencement of general anesthesia). 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 19 Mar 2013.