Intubation; DifficultsupraviewNCT02501577
Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation
A study testing SAD 1 and SAD 2 in people with Intubation; Difficult, run by University of Regensburg at 1 site in Germany.
Trial summary
Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- SAD 1 and SAD 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Oct 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Regensburg
Regensburg, 93051
Thomas Metterlein, MD, +499419440, thomas.metterlein@ukr.de
Christoph Plank, MD, +499419440, christoph.plank@ukr.de
About this study
Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position
Read the detailed description
Feasibility for fiberoptical verification of pharyngeal position of supraglottic airway device
- Conditions
- Intubation; Difficult
- Being tested
- SAD 1, SAD 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAD 1Device
Placement and fiberoptic control
SAD 2Device
Placement and fiberoptic control
| Study group | Role | What they receive |
|---|---|---|
| SAD 1 | Experimental | FOI for placement Receives: Device: SAD 1 |
| SAD 2 | Experimental | FOI für placement Receives: Device: SAD 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of vocal cords
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Metterlein, University of Regensburg
- Investigators
- Thomas Metterlein, MD, Study chair, Uni Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501577
- Sponsor's protocol ID
- sadfoi
- Acronym
- supraview
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation
- ClinicalTrials.gov ID
- NCT02501577
- Acronym / sponsor ID
- supraview / sadfoi
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 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.
Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position
Detailed description
Feasibility for fiberoptical verification of pharyngeal position of supraglottic airway device
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD 1 | Experimental | Device: SAD 1FOI for placement |
| SAD 2 | Experimental | Device: SAD 2FOI für placement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- will to participate
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SAD 1Placement and fiberoptic control | Device | SAD 1 |
| SAD 2Placement and fiberoptic control | Device | SAD 2 |
Primary outcome
Visibility of vocal cords
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Thomas Metterlein, MD study chair
Uni Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAD 1 and SAD 2 in people with Intubation; Difficult, run by University of Regensburg at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 17 Jul 2015. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Metterlein, MD (+499419440, thomas.metterlein@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility of vocal cords (time frame: intraoperative). 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 17 Jul 2015.