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Air-Q in Totally Edentulous and Dentate Geriatric Patients

The Comparison of the Effectiveness of the Self-Pressurizing Air-Q Intubating Laryngeal Airway in Totally Edentulous and Dentate Geriatric Patients

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07138079
Enrollment
50
Registered
2025-08-22
Start date
2025-08-18
Completion date
2025-10-10
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Sore-throat

Keywords

Air-Q Laryngeal İntubating Airway, Oropharyngeal leak pressure, supraglottic airways, Edentulous patients, Geriatric patients

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.

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.

Interventions

OTHERedentulous geriatric patients

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

OTHERdentate geriatric patients

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

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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

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).

Design outcomes

Primary

MeasureTime frameDescription
Measurement of oropharyngeal leak pressure (OLP)One minute after successful LMA placementOne minute after successful LMA placement and fixation, oropharyngeal leak pressure

Secondary

MeasureTime frameDescription
ease of SGA placement3 minutes after induction of anesthesiaSuccessful SGA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Air-Q insertion time3 minutes after induction of anesthesiaSuccessful Air-Q placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
maneuvers required for successful ventilation3 minutes after induction of anesthesiaIt 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.
fiberoptic view grading3 minutes after induction of anesthesiaThe 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.

Other

MeasureTime frameDescription
dysphonia1 hour postoperativelyThe presence or absence of dysphonia will be recorded at the firsth postoperative hour
Sore throat1 hour postoperativelyThe presence or absence of sore throat will be recorded at the 24th postoperative hour
Complications during Air-Q removal (emerge)One minute after Air-Q removalComplications during SP\_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.

Countries

Turkey (Türkiye)

Contacts

Primary ContactZeynep Koç
zeynepyilmazkoc@hotmail.com05345958843

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026