Supraglottic Airway DevicesNCT04365192
Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients
An observational study of Supraglottic Airway Devices, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Supraglottic Airway Devices
- What is being tested?
- I-gel and Self-pressurized air-Q
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 15 Mar 2019
- Phase
- Observational
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 65-85 years old patients who undergo urologic surgery
Who may be able to join
- 65-85 years old
- ASA I-III
- Elective urologic surgery
- Mallampati 1-2
Who cannot join
- BMI>35kg/m2
- Operation time more than 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).
The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.
Read more
The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.
The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.
The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.
- Conditions
- Supraglottic Airway Devices
- Being tested
- I-gel, Self-pressurized air-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gelDevice
The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent.
The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary.
Self-pressurized air-QDevice
The self-pressured air-Q is a supraglottic airway management device The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.
| Study group | Role | What they receive |
|---|---|---|
| I-gel | Not described Receives: Device: I-gel | |
| Self-pressurized air-Q | Not described Receives: Device: Self-pressurized air-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in first attempt
Correct insertion was assessed by proper chest expansion, the presence of a CO2 wave form with a plateau on the capnograph, absence of audible leak, and lack of gastric insufflation.
Measured: 3 minutes
Secondary outcomes (1)
Fiberoptic view grade
Grade 1: whole vocal cords are seen, the epiglottis is not seen at all. Grade 2: larynx plus the posterior surface of epiglottis are seen. Grade 3: the anterior tip of the epiglottis is seen. Grade 4: the anterior tip of the epiglottis is seen and encroaching on the view of vocal cords obstructing <50% of view. Grade 5: the epiglottis is completely obstructing the AQ opening, no view is seen.
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start15 Mar 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway DevicesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Yilmaz Inal, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365192
- Sponsor's protocol ID
- 2013-KAEK-64
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients
- ClinicalTrials.gov ID
- NCT04365192
- Acronym / sponsor ID
- 2013-KAEK-64
- Conditions
- Supraglottic Airway Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 28 Apr 2020 (actual)
- 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 devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).
The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.
The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.
The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.
The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gel | – | Device: I-gel |
| Self-pressurized air-Q | – | Device: Self-pressurized air-Q |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 65-85 years old patients who undergo urologic surgery
Key inclusion criteria (4 listed)
- 65-85 years old
- ASA I-III
- Elective urologic surgery
- Mallampati 1-2
Key exclusion criteria (2 listed)
- BMI>35kg/m2
- Operation time more than 2 hours
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 |
|---|---|---|
| I-gelThe i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. | Device | I-gel |
| Self-pressurized air-QThe self-pressured air-Q is a supraglottic airway management device The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal. | Device | Self-pressurized air-Q |
Primary outcome
Success in first attempt
Time frame: 3 minutes
Correct insertion was assessed by proper chest expansion, the presence of a CO2 wave form with a plateau on the capnograph, absence of audible leak, and lack of gastric insufflation.
1 secondary outcome
Fiberoptic view grade
Time frame: 4 minutes
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 29 Apr 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.
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?
An observational study of Supraglottic Airway Devices, run by Istanbul Medeniyet 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 4 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 29 Apr 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 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.
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 in first attempt (time frame: 3 minutes). 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 29 Apr 2020.