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NCT Number: NCT06563583

Comparison of the Effectiveness of Air-Q SP Among Different Age Groups

Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. This study aims to compare the effectiveness of the Air-Q laryngeal mask airway (LMA) across different age groups (young, middle-aged, and elderly patients) and to evaluate complications associated with supraglottic airways (SGA).

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Key information

About this study

"Supraglottic airway devices (SGA) used perioperatively are known to require lower anesthetic depth and result in fewer airway complications such as coughing and sore throat after awakening from anesthesia compared to endotracheal intubation. Due to these advantages, SGAs are particularly beneficial in elderly patients, as they experience a reduction in functional reserves, are more affected by cardiopulmonary diseases, and are more sensitive to anesthetic drugs

SGAs are inserted through the oral route, and the SGA cuff is placed between the base of the tongue, hypopharynx, and upper esophageal sphincter (UES) to provide proper ventilation. Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. Additionally, there are changes in the function and structure of the UES with age. These age-related changes may affect the performance of SGAs in the elderly population.

Recently, SGAs that do not require manual cuff inflation have been used more frequently in various clinical settings due to the advantages of eliminating the need for manual cuff inflation and cuff pressure monitoring. The Air-Q is connected to an airway tube through a communication port that allows for self-regulation of cuff pressure in response to airway pressure."

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-85 year-old 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

Group 1 will include patients aged 18-40 years

Other

Group 1 will include patients aged 18-40 years.

Group 2 will include patients aged 40-64 years

Other

Group 2 will include patients aged 40-64 years, and finally.

Group 3 will include patients aged 65-85 years

Other

Group 3 will include patients aged 65-85 years.

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 (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.

Secondary outcomes

  1. SP Air-Q insertion time

    Time frame: 3 minutes after induction of anesthesia

    Successful LMA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.

  2. ease of LMA placement

    Time frame: 3 minutes after induction of anesthesia

    The ease of LMA placement will be scored by the anesthesiologist on a scale from 1 to 4 (1: Successful on the first attempt with no resistance from the tissues; 2: Successful on the first attempt but with some tissue resistance during placement; 3: Moderate tissue resistance; 4: Failure to place the LMA).

  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.

  5. Complications during SP_Air-Q removal (emerge)

    Time frame: One minute after SP Air-Q removal

    such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 < 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded

  6. sore throat

    Time frame: 1-24 hours postoperatively

    Postoperative complication

  7. dysphonia

    Time frame: 1-24 hours postpoeratively

    Postoperative complication

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effectiveness of Self-Pressurizing Air-Q Intubating Laryngeal Airways Among Different Age Groups

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Aug 19, 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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