Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06563583
Enrollment
153
Registered
2024-08-21
Start date
2024-09-02
Completion date
2025-03-30
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia, Postoperative Complications, Sore-throat

Keywords

Air-Q SP İntubating Laryngeal Airway, oropharyngeal leak pressure, supraglottic airways

Brief summary

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).

Detailed description

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.

Interventions

OTHERGroup 1 will include patients aged 18-40 years

Group 1 will include patients aged 18-40 years.

OTHERGroup 2 will include patients aged 40-64 years

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

OTHERGroup 3 will include patients aged 65-85 years

Group 3 will include patients aged 65-85 years.

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Measurement of oropharyngeal leak pressure (OLP)One minute after successful LMA placementOne 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

MeasureTime frameDescription
ease of LMA placement3 minutes after induction of anesthesiaThe 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).
maneuvers required for successful ventilation3 minutes after induction of anesthesiaIt 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.
fiberoptic view grading3 minutes after induction of anesthesiaThe 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.
SP Air-Q insertion time3 minutes after induction of anesthesiaSuccessful LMA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
sore throat1-24 hours postoperativelyPostoperative complication
dysphonia1-24 hours postpoerativelyPostoperative complication
Complications during SP_Air-Q removal (emerge)One minute after SP Air-Q removalsuch as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026