Air-Q in Totally Edentulous and Dentate Geriatric Patients

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Complications Sore-throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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edentulous group

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

Group Type ACTIVE_COMPARATOR

edentulous geriatric patients

Intervention Type OTHER

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

gentate group

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

Group Type ACTIVE_COMPARATOR

dentate geriatric patients

Intervention Type OTHER

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

Interventions

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edentulous geriatric patients

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

Intervention Type OTHER

dentate geriatric patients

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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No