Difficult AirwayPhase 4NCT02979171
Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™
A Phase 4 study testing Laryngeal Mask Airway Classic in people with Difficult Airway, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- Laryngeal Mask Airway Classic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Jun 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery
Who cannot join
- High aspiration risk, who take more than 4 hours surgery
- Body mass index greater than of 35 kg/m²
- Disease related to the cervical spine
- The mouth opening is less than 20 mm
Trial locations and contacts
1 site in 1 country.
About this study
Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.
- Conditions
- Difficult Airway
- Being tested
- Laryngeal Mask Airway Classic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Airway ClassicDevice
| Study group | Role | What they receive |
|---|---|---|
| LMA-Classic | Active comparator | airway management with LMA-Classic Receives: Device: Laryngeal Mask Airway Classic |
| LMA-Flexible | Active comparator | airway management with LMA-Flexible Receives: Device: Laryngeal Mask Airway Classic |
| LMA-Proseal | Active comparator | airway management with LMA-Proseal Receives: Device: Laryngeal Mask Airway Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time and attempts in min.
Measured: through study completion, an average of 6 months
oropharyngeal leak pressure in cmH20.
Measured: through study completion, an average of 6 months
fiberoptic view grade by Brimacombe and Berry bronchoscopy score
score1-4 (easy to difficult)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979171
- Sponsor's protocol ID
- 71146310
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™
- ClinicalTrials.gov ID
- NCT02979171
- Acronym / sponsor ID
- 71146310
- Conditions
- Difficult Airway
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Dec 2016 (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.
Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMA-Classic | Active comparator | Device: Laryngeal Mask Airway Classicairway management with LMA-Classic |
| LMA-Flexible | Active comparator | Device: Laryngeal Mask Airway Classicairway management with LMA-Flexible |
| LMA-Proseal | Active comparator | Device: Laryngeal Mask Airway Classicairway management with LMA-Proseal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery
Key exclusion criteria (4 listed)
- High aspiration risk, who take more than 4 hours surgery
- Body mass index greater than of 35 kg/m²
- Disease related to the cervical spine
- The mouth opening is less than 20 mm
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 |
|---|---|---|
| Laryngeal Mask Airway Classic | Device | LMA-Classic, LMA-Flexible, LMA-Proseal |
Primary outcome
insertion time and attempts in min.
Time frame: through study completion, an average of 6 months
oropharyngeal leak pressure in cmH20.
Time frame: through study completion, an average of 6 months
fiberoptic view grade by Brimacombe and Berry bronchoscopy score
Time frame: through study completion, an average of 6 months
score1-4 (easy to difficult)
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 1 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Laryngeal Mask Airway Classic in people with Difficult Airway, run by Marmara University at 1 site in Turkey (Türkiye).
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 4 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 1 Dec 2016. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
insertion time and attempts in min. (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. 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 1 Dec 2016.