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

NCT06563583 | Completed

• 1 other identifier: ZeynepKoc001
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Postoperative Complications; Sore-throat; Airway Complication of Anesthesia

Keywords

Air-Q SP İntubating Laryngeal Airway; oropharyngeal leak pressure; supraglottic airways

Outcome Measures

Primary Outcomes (1)

• 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.

  One minute after successful LMA placement

Secondary Outcomes (7)

• SP Air-Q insertion time

  3 minutes after induction of anesthesia

• ease of LMA placement

  3 minutes after induction of anesthesia

• maneuvers required for successful ventilation

  3 minutes after induction of anesthesia

• fiberoptic view grading

  3 minutes after induction of anesthesia

• Complications during SP_Air-Q removal (emerge)

  One minute after SP Air-Q removal

Study Arms (3)

Group 1

Group 1 will include patients aged 18-40 years.

Other: Group 1 will include patients aged 18-40 years

Group 2

Group 2 will include patients aged 40-64 years.

Other: Group 2 will include patients aged 40-64 years

Group 3

Group 3 will include patients aged 65-85 years.

Other: Group 3 will include patients aged 65-85 years

Interventions

Group 1 will include patients aged 18-40 years OTHER

Group 1 will include patients aged 18-40 years.

Group 1

Group 2 will include patients aged 40-64 years OTHER

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

Group 2

Group 3 will include patients aged 65-85 years OTHER

Group 3 will include patients aged 65-85 years.

Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery under general anesthesia with the use of an SP Air-Q.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30320644 RESULT

• 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.

  PMID: 26634080 RESULT

• 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.

  PMID: 28857785 RESULT

MeSH Terms

Conditions

Postoperative Complications; Pharyngitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 2, 2024
• Primary Completion: November 7, 2024
• Study Completion: March 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)