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NCT Number: NCT07138079

Air-Q in Totally Edentulous and Dentate Geriatric Patients

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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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

edentulous geriatric patients

Other

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

dentate geriatric patients

Other

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

Primary outcomes

  1. Measurement of oropharyngeal leak pressure (OLP)

    Time frame: One minute after successful LMA placement

    One minute after successful LMA placement and fixation, oropharyngeal leak pressure

Secondary outcomes

  1. Air-Q insertion time

    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.

  2. ease of SGA placement

    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.

  3. maneuvers required for successful ventilation

    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.

  4. fiberoptic view grading

    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.

Other outcomes

  1. Complications during Air-Q removal (emerge)

    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.

  2. Sore throat

    Time frame: 1 hour postoperatively

    The presence or absence of sore throat will be recorded at the 24th postoperative hour

  3. Sore throat

    Time frame: 24 hours postoperatively

    The presence or absence of sore throat will be recorded at the 24th postoperative hour

  4. dysphonia

    Time frame: 1 hour postoperatively

    The presence or absence of dysphonia will be recorded at the firsth postoperative hour

  5. dysphonia

    Time frame: 24 hours postoperatively

    The presence or absence of dysphonia will be recorded at the firsth postoperative hour

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Koç

CONTACT

[email protected]

05345958843

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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