NCT07138079

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 15, 2025

Last Update Submit

August 15, 2025

Conditions

Postoperative ComplicationsSore-throat

Keywords

Air-Q Laryngeal İntubating AirwayOropharyngeal leak pressuresupraglottic airwaysEdentulous patientsGeriatric patients

Outcome Measures

Primary Outcomes (1)

  • Measurement of oropharyngeal leak pressure (OLP)

    One minute after successful LMA placement and fixation, oropharyngeal leak pressure

    One minute after successful LMA placement

Secondary Outcomes (4)

  • Air-Q insertion time

    3 minutes after induction of anesthesia

  • ease of SGA 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

Other Outcomes (5)

  • Complications during Air-Q removal (emerge)

    One minute after Air-Q removal

  • Sore throat

    1 hour postoperatively

  • Sore throat

    24 hours postoperatively

  • +2 more other outcomes

Study Arms (2)

edentulous group

ACTIVE COMPARATOR

under general anesthesia, edentulous geriatric patients inserted Air- Q intubating airway

Other: edentulous geriatric patients

gentate group

ACTIVE COMPARATOR

under general anesthesia, dantate geriatric patients inserted Air- Q intubating airway

Other: dentate geriatric patients

Interventions

edentulous geriatric patientsOTHER

Edentulous geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.

edentulous group
dentate geriatric patientsOTHER

Dentate geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.

gentate group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27366552BACKGROUND

  • Genez 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.

    PMID: 28618734BACKGROUND

  • 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: 30320644BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsPharyngitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Zeynep Koç

CONTACT

05345958843zeynepyilmazkoc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

August 18, 2025

Primary Completion

September 29, 2025

Study Completion

October 10, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)