Nasal ObstructionAirtraqMobNCT02510924
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq
A study testing Tracheal intubation in people with Nasal Obstruction and Arthrosis, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Airtraq sp has been proven effective for intubating patients presenting with difficult airway. The Airtraq sp allows visualisation of the tracheal inlet only for the intubator. By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Arthrosis
- What is being tested?
- Tracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to 5 Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent
Who cannot join
- American Society of Anesthesia classification 4, patient refusal, history of difficult airway
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dpt of Anesthesiology, University of Lausanne CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq in Adults With a Simulated Difficult Airway With a Cervical-spine Collar
Airtraq sp has been proven effective for intubating patients presenting with difficult airway.
The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.
By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.
The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.
Read the detailed description
Airtraq sp has been proven effective for intubating patients presenting with difficult airway.
The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.
By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.
The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway.
Patients will be included if they necessitate an elective general anesthesia and orotracheal intubation.
Exclusion criteria are related to difficult airway, ASA IV and patient refusal.
- Conditions
- Nasal Obstruction, Arthrosis
- Being tested
- Tracheal intubation
- Keywords
- Intubation, Airtraq, General anesthesia, Difficult airway
- Medical subject headings
- Nasal Obstruction, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubationDevice
tracheal intubation with Airtraq sp vs Airtraq mobile
| Study group | Role | What they receive |
|---|---|---|
| Tracheal intubation with Airtraq sp | Active comparator | Tracheal intubation with Airtraq sp. Receives: Device: Tracheal intubation |
| Tracheal intubation with Airtraq Mobile | Experimental | Tracheal intubation with Airtraq Mobile Receives: Device: Tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Success of intubation within time frame
Measured: 180 seconds
Secondary outcomes (2)
Number of attempts
Success of intubation within time frame
Measured: 180 seconds
Number of injuries
Injuries within time frame
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion5 Nov 2017
- Study completion5 Nov 2017
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 Nasal ObstructionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker,MD PD, University of Lausanne Hospitals
- Investigators
- Patrick Schoettker, MD, PD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510924
- Sponsor's protocol ID
- 409/14
- Acronym
- AirtraqMob
- Status last verified
- Dec 2017
- First submitted
- 27 Jul 2015
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoettker P, Corniche J. The AirView Study: Comparison of Intubation Conditions and Ease between the Airtraq-AirView and the King Vision. Biomed Res Int. 2015;2015:284142. doi: 10.1155/2015/284142. Epub 2015 Jun 16.
PubMed 26161393
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq in Adults With a Simulated Difficult Airway With a Cervical-spine Collar
- ClinicalTrials.gov ID
- NCT02510924
- Acronym / sponsor ID
- AirtraqMob / 409/14
- Conditions
- Nasal Obstruction, Arthrosis
- Keywords
- Intubation, Airtraq, General anesthesia, Difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 5 Nov 2017 (actual)
- First posted
- 29 Jul 2015 (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.
Airtraq sp has been proven effective for intubating patients presenting with difficult airway.
The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.
By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.
The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.
Detailed description
Airtraq sp has been proven effective for intubating patients presenting with difficult airway.
The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.
By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.
The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway.
Patients will be included if they necessitate an elective general anesthesia and orotracheal intubation.
Exclusion criteria are related to difficult airway, ASA IV and patient refusal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal intubation with Airtraq sp | Active comparator | Device: Tracheal intubationTracheal intubation with Airtraq sp. |
| Tracheal intubation with Airtraq Mobile | Experimental | Device: Tracheal intubationTracheal intubation with Airtraq Mobile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent
Key exclusion criteria (1 listed)
- American Society of Anesthesia classification 4, patient refusal, history of difficult airway
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 |
|---|---|---|
| Tracheal intubationtracheal intubation with Airtraq sp vs Airtraq mobile | Device | Tracheal intubation with Airtraq Mobile, Tracheal intubation with Airtraq sp |
Primary outcome
Success
Time frame: 180 seconds
Success of intubation within time frame
2 secondary outcomes
Number of attempts
Time frame: 180 seconds
Number of injuries
Time frame: 180 seconds
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 2 Jan 2018.
- Background: PubMed 26161393Schoettker P, Corniche J. The AirView Study: Comparison of Intubation Conditions and Ease between the Airtraq-AirView and the King Vision. Biomed Res Int. 2015;2015:284142. doi: 10.1155/2015/284142. Epub 2015 Jun 16.
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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.
Patrick Schoettker, MD, PD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation in people with Nasal Obstruction and Arthrosis, run by University of Lausanne Hospitals 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 1 inclusion and 1 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 2 Jan 2018. 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.
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?
Success (time frame: 180 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 NCT02510924, 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 2 Jan 2018.