Zeynep Koç
Yenimahalle, Ankara, Turkey (Türkiye)
NCT Number: NCT07138079
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 opening soon.
Get Notified65 year–90 year
All sexes
Interventional
Not applicable
Yenimahalle, Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: One minute after successful LMA placement
One minute after successful LMA placement and fixation, oropharyngeal leak pressure
Time frame: 3 minutes after induction of anesthesia
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
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
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
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: One minute after Air-Q removal
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: 1 hour postoperatively
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame: 24 hours postoperatively
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame: 1 hour postoperatively
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Time frame: 24 hours postoperatively
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Contact information is provided by the study sponsor or research team.
Diskapi Yildirim Beyazit Education and Research Hospital
Other Gov
The Comparison of the Effectiveness of the Self-Pressurizing Air-Q Intubating Laryngeal Airway in Totally Edentulous and Dentate Geriatric Patients
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