Comparison of the Effectiveness of SPAir-Q Among Different Age Groups

Recruiting

• Conditions: Postoperative Complications; Sore-throat; Airway Complication of Anesthesia
• Interventions: Other: Group 1 will include patients aged 18-40 years; Other: Group 2 will include patients aged 40-64 years; Other: Group 3 will include patients aged 65-85 years

• Registration Number: NCT06563583
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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."

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-09-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Primary Completion: 2024-11-07
• Last Update Posted: 2024-11-07
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Group 1 will include patients aged 18-40 years	Group 1 will include patients aged 18-40 years.
Group 2	Group 2 will include patients aged 40-64 years	Group 2 will include patients aged 40-64 years.
Group 3	Group 3 will include patients aged 65-85 years	Group 3 will include patients aged 65-85 years.

Primary Outcome Measures

Name	Time	Method
Measurement of oropharyngeal leak pressure (OLP)	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 Outcome Measures

Name	Time	Method
SP Air-Q insertion time	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.
ease of LMA placement	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).
maneuvers required for successful ventilation	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.
fiberoptic view grading	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.
Complications during SP_Air-Q removal (emerge)	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
sore throat	1-24 hours postoperatively	Postoperative complication
dysphonia	1-24 hours postpoeratively	Postoperative complication

Trial Locations

Locations (1)

Zeynep Koç; 🇹🇷 Yenimahalle, Ankara, Turkey