Postoperative ComplicationsNCT07138079
Air-Q in Totally Edentulous and Dentate Geriatric Patients
A study testing edentulous geriatric patients and dentate geriatric patients in people with Postoperative Complications and Sore-throat, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Complications, Sore-throat
- What is being tested?
- edentulous geriatric patients and dentate geriatric patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65-90 year-old patients
- Edentulous and gentate patients
- American Society of Anesthesiologist Physical Status classification I-III,
- Undergoing an elective operation under general anesthesia in our hospital
Who cannot join
- Predicted difficult airway (Mallampati class 4, mouth opening < 3 cm, or thyromental distance < 6 cm)
- Body mass index (BMI) > 40 kg/m2
- Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),
- Unstable vital signs
- Cervical spine problems, Respiratory complications (e.g. recent pneumonia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Comparison of the Effectiveness of the Self-Pressurizing Air-Q Intubating Laryngeal Airway in Totally Edentulous and Dentate Geriatric Patients
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.
Read the detailed description
In the elderly population, the prevalence of totally edentulous patients over the age of 65 exceeds 60%. With aging, parapharyngeal fat deposition increases and contributes to pharyngeal collapse in elderly patients . In elderly patients with total tooth loss, face mask ventilation is difficult because standard face masks do not fit well on edentulous faces. Additionally, during general anesthesia, loss of muscle tone, reduced oropharyngeal air space, posterior displacement of the tongue, and airway obstruction caused by the soft palate and epiglottis all make ventilation challenging . Structural changes in the airway, combined with age-related physiological alterations in respiration, may reduce oxygen saturation, blunt the hypoxic response, and increase the risk of postoperative respiratory complications. Due to age-related acquired changes in pharyngeal muscle activity, the likelihood of skeletal structural abnormalities such as retrognathia-often associated with difficult airways-has been proposed (2). Therefore, these age-related changes may influence the clinical performance of supraglottic airway devices (SADs).
Recently, SADs that do not require manual cuff inflation have gained popularity in various clinical settings due to their advantage of eliminating the need for manual cuff inflation and cuff pressure monitoring (5,6). The Air-Q is a supraglottic airway device that connects to an airway tube through a communication port, allowing self-pressurization of the cuff in response to airway pressure.
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.
- Conditions
- Postoperative Complications, Sore-throat
- Being tested
- edentulous geriatric patients, dentate geriatric patients
- Keywords
- Air-Q Laryngeal İntubating Airway, Oropharyngeal leak pressure, supraglottic airways, Edentulous patients, Geriatric patients
- Medical subject headings
- Postoperative Complications, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edentulous geriatric patientsOther
Edentulous geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
dentate geriatric patientsOther
Dentate geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| edentulous group | Active comparator | under general anesthesia, edentulous geriatric patients inserted Air- Q intubating airway Receives: Other: edentulous geriatric patients |
| gentate group | Active comparator | under general anesthesia, dantate geriatric patients inserted Air- Q intubating airway Receives: Other: dentate geriatric patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oropharyngeal leak pressure (OLP)
One minute after successful LMA placement and fixation, oropharyngeal leak pressure
Measured: One minute after successful LMA placement
Secondary outcomes (4)
Air-Q insertion time
Successful Air-Q placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Measured: 3 minutes after induction of anesthesia
ease of SGA placement
Successful SGA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Measured: 3 minutes after induction of anesthesia
maneuvers required for successful ventilation
It will be recorded whether any further maneuvers are required: Gentle pushing or pulling of the LMA to adjust its depth, jaw-thrust maneuver, and flexion or extension of the head.
Measured: 3 minutes after induction of anesthesia
fiberoptic view grading
The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.
Measured: 3 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion29 Sep 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Koc, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138079
- Sponsor's protocol ID
- ZeynepKoc004
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beydes T, Kucukguclu S, Ozbilgin S, Kuvaki B, Ademoglu M, Sari M. Comparison of Laryngeal Mask Airway Supreme(TM) Versus Unique(TM) in Edentulous Geriatric Patients. Turk J Anaesthesiol Reanim. 2016 Feb;44(1):32-6. doi: 10.5152/TJAR.2016.22129. Epub 2016 Feb 1.
PubMed 27366552Genez M, Kucukguclu S, Ozbilgin S, Kuvaki B, Beydes T, Aksoy Sari M. A comparison of usage of the laryngeal mask UniqueTM in denticulate and edentulate geriatric patients. Turk J Med Sci. 2017 Jun 12;47(3):854-860. doi: 10.3906/sag-1603-206.
PubMed 28618734Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
PubMed 30320644
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effectiveness of the Self-Pressurizing Air-Q Intubating Laryngeal Airway in Totally Edentulous and Dentate Geriatric Patients
- ClinicalTrials.gov ID
- NCT07138079
- Acronym / sponsor ID
- ZeynepKoc004
- Conditions
- Postoperative Complications, Sore-throat
- Keywords
- Air-Q Laryngeal İntubating Airway, Oropharyngeal leak pressure, supraglottic airways, Edentulous patients, Geriatric patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 29 Sep 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 22 Aug 2025 (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.
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.
Detailed description
In the elderly population, the prevalence of totally edentulous patients over the age of 65 exceeds 60%. With aging, parapharyngeal fat deposition increases and contributes to pharyngeal collapse in elderly patients . In elderly patients with total tooth loss, face mask ventilation is difficult because standard face masks do not fit well on edentulous faces. Additionally, during general anesthesia, loss of muscle tone, reduced oropharyngeal air space, posterior displacement of the tongue, and airway obstruction caused by the soft palate and epiglottis all make ventilation challenging . Structural changes in the airway, combined with age-related physiological alterations in respiration, may reduce oxygen saturation, blunt the hypoxic response, and increase the risk of postoperative respiratory complications. Due to age-related acquired changes in pharyngeal muscle activity, the likelihood of skeletal structural abnormalities such as retrognathia-often associated with difficult airways-has been proposed (2). Therefore, these age-related changes may influence the clinical performance of supraglottic airway devices (SADs).
Recently, SADs that do not require manual cuff inflation have gained popularity in various clinical settings due to their advantage of eliminating the need for manual cuff inflation and cuff pressure monitoring (5,6). The Air-Q is a supraglottic airway device that connects to an airway tube through a communication port, allowing self-pressurization of the cuff in response to airway pressure.
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| edentulous group | Active comparator | Other: edentulous geriatric patientsunder general anesthesia, edentulous geriatric patients inserted Air- Q intubating airway |
| gentate group | Active comparator | Other: dentate geriatric patientsunder general anesthesia, dantate geriatric patients inserted Air- Q intubating airway |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65-90 year-old patients
- Edentulous and gentate patients
- American Society of Anesthesiologist Physical Status classification I-III,
- Undergoing an elective operation under general anesthesia in our hospital
Key exclusion criteria (5 listed)
- Predicted difficult airway (Mallampati class 4, mouth opening < 3 cm, or thyromental distance < 6 cm)
- Body mass index (BMI) > 40 kg/m2
- Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),
- Unstable vital signs
- Cervical spine problems, Respiratory complications (e.g. recent pneumonia).
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 |
|---|---|---|
| edentulous geriatric patientsEdentulous geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia. | Other | edentulous group |
| dentate geriatric patientsDentate geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia. | Other | gentate group |
Primary outcome
Measurement of oropharyngeal leak pressure (OLP)
Time frame: One minute after successful LMA placement
One minute after successful LMA placement and fixation, oropharyngeal leak pressure
4 secondary outcomes
Air-Q insertion time
Time frame: 3 minutes after induction of anesthesia
ease of SGA placement
Time frame: 3 minutes after induction of anesthesia
maneuvers required for successful ventilation
Time frame: 3 minutes after induction of anesthesia
fiberoptic view grading
Time frame: 3 minutes after induction of anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 27366552Beydes T, Kucukguclu S, Ozbilgin S, Kuvaki B, Ademoglu M, Sari M. Comparison of Laryngeal Mask Airway Supreme(TM) Versus Unique(TM) in Edentulous Geriatric Patients. Turk J Anaesthesiol Reanim. 2016 Feb;44(1):32-6. doi: 10.5152/TJAR.2016.22129. Epub 2016 Feb 1.
- Background: PubMed 28618734Genez M, Kucukguclu S, Ozbilgin S, Kuvaki B, Beydes T, Aksoy Sari M. A comparison of usage of the laryngeal mask UniqueTM in denticulate and edentulate geriatric patients. Turk J Med Sci. 2017 Jun 12;47(3):854-860. doi: 10.3906/sag-1603-206.
- Background: PubMed 30320644Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing edentulous geriatric patients and dentate geriatric patients in people with Postoperative Complications and Sore-throat, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 5 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: opening soon, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Koç (05345958843, zeynepyilmazkoc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oropharyngeal leak pressure (OLP) (time frame: One minute after successful LMA placement). 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 NCT07138079, which also lists 3 linked publications.
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 22 Aug 2025.