Clinical trial NCT06563583: Comparison of the Effectiveness of SPAir-Q Among Different Age Groups
Official title: Comparison of the Effectiveness of Self-Pressurizing Air-Q Intubating Laryngeal Airways Among Different Age Groups
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Sore-throat
Airway Complication of Anesthesia
Keywords: Air-Q Laryngeal İntubating Airway
Oropharyngeal leak pressure
supraglottic airways
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery under general anesthesia with the use of an SP Air-Q.

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."

Eligibility criteria: 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).

Primary outcomes:
measure: Measurement of oropharyngeal leak pressure (OLP)
timeFrame: One minute after successful LMA placement
Secondary outcomes:
measure: SP Air-Q insertion time
timeFrame: 3 minutes after induction of anesthesia
measure: ease of LMA placement
timeFrame: 3 minutes after induction of anesthesia
measure: maneuvers required for successful ventilation
timeFrame: 3 minutes after induction of anesthesia
measure: fiberoptic view grading
timeFrame: 3 minutes after induction of anesthesia
measure: Complications during SP_Air-Q removal (emerge)
timeFrame: One minute after SP Air-Q removal
measure: sore throat
timeFrame: 1-24 hours postoperatively
measure: dysphonia
timeFrame: 1-24 hours postpoeratively
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Zeynep Koç
state: Ankara
Study officials:
References:
citation: Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
citation: Kim EM, Kim MS, Koo BN, Lee JR, Lee YS, Lee JH. Clinical efficacy of the classic laryngeal mask airway in elderly patients: a comparison with young adult patients. Korean J Anesthesiol. 2015 Dec;68(6):568-74. doi: 10.4097/kjae.2015.68.6.568. Epub 2015 Nov 25.
citation: Kim MH, Lee JH, Choi YS, Park S, Shin S. Comparison of the laryngeal mask airway supreme and the i-gel in paralysed elderly patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):598-604. doi: 10.1097/EJA.0000000000000700.