Single Lung VentilationNCT03817879
Double-lumen Tubes (DLT) - Health Economic Study
A study testing VivaSight double-lumen tube for single-lung ventilation and Conventional double-lument tube for single-lung ventilation in people with Single Lung Ventilation and Thoracic Surgery, run by Ambu A/S at 1 site in Denmark.
Trial summary
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Lung Ventilation, Thoracic Surgery, Anesthesia
- What is being tested?
- VivaSight double-lumen tube for single-lung ventilation and Conventional double-lument tube for single-lung ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
- The subject or legal representative has signed the Informed Consent
- The subject is admitted at Odense University Hospital (OUH), department V
- Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
- Subjects > 18 years of age
Who cannot join
- Subjects with known tracheobronchial anatomic anomalies
- Subjects going for emergency procedures
- Subjects with anticipated difficult airways
- Subjects with known tracheal pathology
- Subjects requiring rapid sequence induction
- Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
Show all 9Show fewer
- Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
- Subjects requiring a right-sided DLT
- Subjects who had participated in the study before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.
Read the detailed description
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.
The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.
- Being tested
- VivaSight double-lumen tube for single-lung ventilation, Conventional double-lument tube for single-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivaSight double-lumen tube for single-lung ventilationProcedure or surgery
Procedure using a tube with a camera
Conventional double-lument tube for single-lung ventilationProcedure or surgery
Procedure using a tube without a camera
| Study group | Role | What they receive |
|---|---|---|
| VivaSight double-lumen tube | Experimental | Not described Receives: Procedure: VivaSight double-lumen tube for single-lung ventilation |
| Conventional double-lumen tube | Active comparator | Not described Receives: Procedure: Conventional double-lument tube for single-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Times Bronchoscope is Used
Measured: During procedure, up to 4 hours
Secondary outcomes (5)
Intubation Time
Measured: During procedure, up to 4 hours
Number of Intubation Attempts
Measured: During procedure, up to 4 hours
Number of Time the Tube Was Repositioned
Measured: During procedure, up to 4 hours
Number of Times Repositioning of the Tube Was Prevented
Measured: During procedure, up to 4 hours
Cost Per Procedure
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start2 Nov 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single Lung VentilationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817879
- Sponsor's protocol ID
- CIS-009
- Status last verified
- Oct 2019
- First submitted
- 9 Jan 2019
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will described in groups
Publications
Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.
PubMed 31297752
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03817879
- Acronym / sponsor ID
- CIS-009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 13 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.
Detailed description
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.
The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VivaSight double-lumen tube | Experimental | Procedure: VivaSight double-lumen tube for single-lung ventilation |
| Conventional double-lumen tube | Active comparator | Procedure: Conventional double-lument tube for single-lung ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
- The subject or legal representative has signed the Informed Consent
- The subject is admitted at Odense University Hospital (OUH), department V
- Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
- Subjects > 18 years of age
Key exclusion criteria (9 listed)
- Subjects with known tracheobronchial anatomic anomalies
- Subjects going for emergency procedures
- Subjects with anticipated difficult airways
- Subjects with known tracheal pathology
- Subjects requiring rapid sequence induction
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 |
|---|---|---|
| VivaSight double-lumen tube for single-lung ventilationProcedure using a tube with a camera | Procedure or surgery | VivaSight double-lumen tube |
| Conventional double-lument tube for single-lung ventilationProcedure using a tube without a camera | Procedure or surgery | Conventional double-lumen tube |
Primary outcome
Number of Times Bronchoscope is Used
Time frame: During procedure, up to 4 hours
5 secondary outcomes
Intubation Time
Time frame: During procedure, up to 4 hours
Number of Intubation Attempts
Time frame: During procedure, up to 4 hours
Number of Time the Tube Was Repositioned
Time frame: During procedure, up to 4 hours
Number of Times Repositioning of the Tube Was Prevented
Time frame: During procedure, up to 4 hours
Cost Per Procedure
Time frame: An average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31297752Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.
- Individual participant dataSharing planned: No. Data will described in groups
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VivaSight double-lumen tube for single-lung ventilation and Conventional double-lument tube for single-lung ventilation in people with Single Lung Ventilation and Thoracic Surgery, run by Ambu A/S at 1 site in Denmark.
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 9 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 13 Feb 2020. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Times Bronchoscope is Used (time frame: During procedure, up to 4 hours). 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 NCT03817879, 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 13 Feb 2020.