Nasal ObstructionS-GuideNCT02519647
Comparison of Intubation Conditions Between the Gliderite and the S-Guide
A study testing Tracheal intubation with Gliderite and Tracheal intubation with S-guide in people with Nasal Obstruction and Lumbar Stenosis, Familial, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways. 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, Lumbar Stenosis, Familial
- What is being tested?
- Tracheal intubation with Gliderite and Tracheal intubation with S-guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2015to 2 Jun 2016
- 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
- Surgery necessitating general anesthesia and orotracheal intubation
Who cannot join
- History or criteria of difficult intubation
- Patient refusal
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: Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.
Read the detailed description
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.
The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.
- Conditions
- Nasal Obstruction, Lumbar Stenosis, Familial
- Being tested
- Tracheal intubation with Gliderite, Tracheal intubation with S-guide
- Medical subject headings
- Nasal Obstruction, Lumbar Stenosis, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation with GlideriteDevice
Tracheal intubation with Gliderite
Tracheal intubation with S-guideDevice
Tracheal intubation with S-guide
| Study group | Role | What they receive |
|---|---|---|
| tracheal intubation with Gliderite | Active comparator | Gliderite will be used for intubation Receives: Device: Tracheal intubation with Gliderite |
| Tracheal intubation with S-Guide | Experimental | S-Guide will be used for intubation Receives: Device: Tracheal intubation with S-guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time necessary to intubate
Time needed to pass tracheal tube through vocal cords
Measured: 50 seconds
Secondary outcomes (3)
Standardized questionnaire assessing injury after intubation
Assessment of discomfort after procedure
Measured: 50 seconds
Standardized questionnaire assessing ease of use of the intubation
assessment by doctor of ease of intubation
Measured: 50 seconds
Subjective ease of use of the intubation assessed by questionnaire
assessment by doctor of ease of intubation
Measured: 50 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion2 May 2016
- Study completion2 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT02519647
- Sponsor's protocol ID
- 267/15
- Acronym
- S-Guide
- Status last verified
- Feb 2020
- First submitted
- 27 Jul 2015
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways
- ClinicalTrials.gov ID
- NCT02519647
- Acronym / sponsor ID
- S-Guide / 267/15
- Conditions
- Nasal Obstruction, Lumbar Stenosis, Familial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 2 May 2016 (actual)
- Study completion
- 2 Jun 2016 (actual)
- First posted
- 11 Aug 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.
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.
Detailed description
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.
The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tracheal intubation with Gliderite | Active comparator | Device: Tracheal intubation with GlideriteGliderite will be used for intubation |
| Tracheal intubation with S-Guide | Experimental | Device: Tracheal intubation with S-guideS-Guide will be used for intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgery necessitating general anesthesia and orotracheal intubation
Key exclusion criteria (2 listed)
- History or criteria of difficult intubation
- 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 |
|---|---|---|
| Tracheal intubation with GlideriteTracheal intubation with Gliderite | Device | tracheal intubation with Gliderite |
| Tracheal intubation with S-guideTracheal intubation with S-guide | Device | Tracheal intubation with S-Guide |
Primary outcome
Time necessary to intubate
Time frame: 50 seconds
Time needed to pass tracheal tube through vocal cords
3 secondary outcomes
Standardized questionnaire assessing injury after intubation
Time frame: 50 seconds
Standardized questionnaire assessing ease of use of the intubation
Time frame: 50 seconds
Subjective ease of use of the intubation assessed by questionnaire
Time frame: 50 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 Mar 2020.
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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 with Gliderite and Tracheal intubation with S-guide in people with Nasal Obstruction and Lumbar Stenosis, Familial, 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 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 2 Mar 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 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?
Time necessary to intubate (time frame: 50 seconds). 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 2 Mar 2020.