Postoperative ComplicationsNCT06563583
Comparison of the Effectiveness of Air-Q SP Among Different Age Groups
An observational study of Postoperative Complications and Sore-throat, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Complications, Sore-throat, Airway Complication of Anesthesia
- What is being tested?
- Group 1 will include patients aged 18-40 years, Group 2 will include patients aged 40-64 years and Group 3 will include patients aged 65-85 years
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 30 Mar 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery under general anesthesia with the use of an SP Air-Q.
Who may be able to join
- 18-85 year-old 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.
About this study
Official title: Comparison of the Effectiveness of Self-Pressurizing Air-Q Intubating Laryngeal Airways Among Different Age Groups
Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. This study aims to compare the effectiveness of the Air-Q laryngeal mask airway (LMA) across different age groups (young, middle-aged, and elderly patients) and to evaluate complications associated with supraglottic airways (SGA).
Read the detailed description
"Supraglottic airway devices (SGA) used perioperatively are known to require lower anesthetic depth and result in fewer airway complications such as coughing and sore throat after awakening from anesthesia compared to endotracheal intubation. Due to these advantages, SGAs are particularly beneficial in elderly patients, as they experience a reduction in functional reserves, are more affected by cardiopulmonary diseases, and are more sensitive to anesthetic drugs
SGAs are inserted through the oral route, and the SGA cuff is placed between the base of the tongue, hypopharynx, and upper esophageal sphincter (UES) to provide proper ventilation. Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. Additionally, there are changes in the function and structure of the UES with age. These age-related changes may affect the performance of SGAs in the elderly population.
Recently, SGAs that do not require manual cuff inflation have been used more frequently in various clinical settings due to the advantages of eliminating the need for manual cuff inflation and cuff pressure monitoring. The Air-Q is connected to an airway tube through a communication port that allows for self-regulation of cuff pressure in response to airway pressure."
- Being tested
- Group 1 will include patients aged 18-40 years, Group 2 will include patients aged 40-64 years, Group 3 will include patients aged 65-85 years
- Keywords
- Air-Q SP İntubating Laryngeal Airway, oropharyngeal leak pressure, supraglottic airways
- 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.
Group 1 will include patients aged 18-40 yearsOther
Group 1 will include patients aged 18-40 years.
Group 2 will include patients aged 40-64 yearsOther
Group 2 will include patients aged 40-64 years, and finally.
Group 3 will include patients aged 65-85 yearsOther
Group 3 will include patients aged 65-85 years.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 will include patients aged 18-40 years. Receives: Other: Group 1 will include patients aged 18-40 years | |
| Group 2 | Group 2 will include patients aged 40-64 years. Receives: Other: Group 2 will include patients aged 40-64 years | |
| Group 3 | Group 3 will include patients aged 65-85 years. Receives: Other: Group 3 will include patients aged 65-85 years |
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 (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.
Measured: One minute after successful LMA placement
Secondary outcomes (7)
SP Air-Q insertion time
Successful LMA 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 LMA placement
The ease of LMA placement will be scored by the anesthesiologist on a scale from 1 to 4 (1: Successful on the first attempt with no resistance from the tissues; 2: Successful on the first attempt but with some tissue resistance during placement; 3: Moderate tissue resistance; 4: Failure to place the LMA).
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
Complications during SP_Air-Q removal (emerge)
such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 < 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded
Measured: One minute after SP Air-Q removal
sore throat
Postoperative complication
Measured: 1-24 hours postoperatively
dysphonia
Postoperative complication
Measured: 1-24 hours postpoeratively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start2 Sep 2024
- Primary completion7 Nov 2024
- Study completion30 Mar 2025
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
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
- NCT06563583
- Sponsor's protocol ID
- ZeynepKoc001
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee 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 30320644Kim EM, Kim MS, Koo BN, Lee JR, Lee YS, Lee JH. Clinical efficacy of the classic laryngeal mask airway in elderly patients: a comparison with young adult patients. Korean J Anesthesiol. 2015 Dec;68(6):568-74. doi: 10.4097/kjae.2015.68.6.568. Epub 2015 Nov 25.
PubMed 26634080Kim MH, Lee JH, Choi YS, Park S, Shin S. Comparison of the laryngeal mask airway supreme and the i-gel in paralysed elderly patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):598-604. doi: 10.1097/EJA.0000000000000700.
PubMed 28857785
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Self-Pressurizing Air-Q Intubating Laryngeal Airways Among Different Age Groups
- ClinicalTrials.gov ID
- NCT06563583
- Acronym / sponsor ID
- ZeynepKoc001
- Keywords
- Air-Q SP İntubating Laryngeal Airway, oropharyngeal leak pressure, supraglottic airways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 21 Aug 2024 (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.
Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. This study aims to compare the effectiveness of the Air-Q laryngeal mask airway (LMA) across different age groups (young, middle-aged, and elderly patients) and to evaluate complications associated with supraglottic airways (SGA).
Detailed description
"Supraglottic airway devices (SGA) used perioperatively are known to require lower anesthetic depth and result in fewer airway complications such as coughing and sore throat after awakening from anesthesia compared to endotracheal intubation. Due to these advantages, SGAs are particularly beneficial in elderly patients, as they experience a reduction in functional reserves, are more affected by cardiopulmonary diseases, and are more sensitive to anesthetic drugs
SGAs are inserted through the oral route, and the SGA cuff is placed between the base of the tongue, hypopharynx, and upper esophageal sphincter (UES) to provide proper ventilation. Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. Additionally, there are changes in the function and structure of the UES with age. These age-related changes may affect the performance of SGAs in the elderly population.
Recently, SGAs that do not require manual cuff inflation have been used more frequently in various clinical settings due to the advantages of eliminating the need for manual cuff inflation and cuff pressure monitoring. The Air-Q is connected to an airway tube through a communication port that allows for self-regulation of cuff pressure in response to airway pressure."
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Group 1 will include patients aged 18-40 yearsGroup 1 will include patients aged 18-40 years. |
| Group 2 | – | Other: Group 2 will include patients aged 40-64 yearsGroup 2 will include patients aged 40-64 years. |
| Group 3 | – | Other: Group 3 will include patients aged 65-85 yearsGroup 3 will include patients aged 65-85 years. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia with the use of an SP Air-Q.
Key inclusion criteria (3 listed)
- 18-85 year-old 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 |
|---|---|---|
| Group 1 will include patients aged 18-40 yearsGroup 1 will include patients aged 18-40 years. | Other | Group 1 |
| Group 2 will include patients aged 40-64 yearsGroup 2 will include patients aged 40-64 years, and finally. | Other | Group 2 |
| Group 3 will include patients aged 65-85 yearsGroup 3 will include patients aged 65-85 years. | Other | Group 3 |
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 (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.
7 secondary outcomes
SP Air-Q insertion time
Time frame: 3 minutes after induction of anesthesia
ease of LMA 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
Complications during SP_Air-Q removal (emerge)
Time frame: One minute after SP Air-Q removal
sore throat
Time frame: 1-24 hours postoperatively
dysphonia
Time frame: 1-24 hours postpoeratively
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 19 Aug 2025.
- Results publication: 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.
- Results publication: PubMed 26634080Kim EM, Kim MS, Koo BN, Lee JR, Lee YS, Lee JH. Clinical efficacy of the classic laryngeal mask airway in elderly patients: a comparison with young adult patients. Korean J Anesthesiol. 2015 Dec;68(6):568-74. doi: 10.4097/kjae.2015.68.6.568. Epub 2015 Nov 25.
- Results publication: PubMed 28857785Kim MH, Lee JH, Choi YS, Park S, Shin S. Comparison of the laryngeal mask airway supreme and the i-gel in paralysed elderly patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):598-604. doi: 10.1097/EJA.0000000000000700.
- 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. 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 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 3 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: finished, as of the sponsor's last update on 19 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?
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?
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 NCT06563583, 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 19 Aug 2025.