An interventional study of edentulous geriatric patients and dentate geriatric patients in Postoperative Complications and Sore-throat, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 50 is below the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
under general anesthesia, edentulous geriatric patients inserted Air- Q intubating airway
Other: edentulous geriatric patients
under general anesthesia, dantate geriatric patients inserted Air- Q intubating airway
Other: dentate geriatric patients
Edentulous geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
Dentate geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
Measurement of oropharyngeal leak pressure (OLP)
One minute after successful LMA placement and fixation, oropharyngeal leak pressure
Time frame: One minute after successful LMA placement
Air-Q insertion time
Successful Air-Q placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Time frame: 3 minutes after induction of anesthesia
ease of SGA placement
Successful SGA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Time frame: 3 minutes after induction of anesthesia
maneuvers required for successful ventilation
It 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.
Time frame: 3 minutes after induction of anesthesia
fiberoptic view grading
The 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.
Time frame: 3 minutes after induction of anesthesia
Complications during Air-Q removal (emerge)
Complications 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.
Time frame: One minute after Air-Q removal
Sore throat
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame: 1 hour postoperatively
Sore throat
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame: 24 hours postoperatively
dysphonia
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Time frame: 1 hour postoperatively
dysphonia
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Time frame: 24 hours postoperatively
Plan to share: No
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Diskapi Yildirim Beyazit Education and Research Hospital