Air-Q in Totally Edentulous and Dentate Geriatric Patients

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Not yet enrolling

Conditions: Postoperative Complications; Sore-throat

Treatments: Other: edentulous geriatric patients; Other: dentate geriatric patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07138079

ZeynepKoc004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

edentulous group

Active Comparator group

Description:

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

Treatment:

Other: edentulous geriatric patients

gentate group

Active Comparator group

Description:

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

Treatment:

Other: dentate geriatric patients