Comparison of the Effectiveness of Air-Q SP Among Different Age Groups

NCT ID: NCT06563583

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-02

Study Completion Date

2025-03-30

Brief Summary

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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

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"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."

Conditions

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Postoperative Complications Sore-throat Airway Complication of Anesthesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Group 1 will include patients aged 18-40 years.

Group 1 will include patients aged 18-40 years

Intervention Type OTHER

Group 1 will include patients aged 18-40 years.

Group 2

Group 2 will include patients aged 40-64 years.

Group 2 will include patients aged 40-64 years

Intervention Type OTHER

Group 2 will include patients aged 40-64 years, and finally.

Group 3

Group 3 will include patients aged 65-85 years.

Group 3 will include patients aged 65-85 years

Intervention Type OTHER

Group 3 will include patients aged 65-85 years.

Interventions

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Group 1 will include patients aged 18-40 years

Group 1 will include patients aged 18-40 years.

Intervention Type OTHER

Group 2 will include patients aged 40-64 years

Group 2 will include patients aged 40-64 years, and finally.

Intervention Type OTHER

Group 3 will include patients aged 65-85 years

Group 3 will include patients aged 65-85 years.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-85 year-old patients
* American Society of Anesthesiologist Physical Status classification I-III,
* Undergoing an elective operation under general anesthesia in our hospital

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zeynep Koc

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30320644 (View on PubMed)

Kim 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.

Reference Type RESULT
PMID: 26634080 (View on PubMed)

Kim 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.

Reference Type RESULT
PMID: 28857785 (View on PubMed)

Other Identifiers

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ZeynepKoc001

Identifier Type: -

Identifier Source: org_study_id

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