Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients

Completed

• Conditions: Supraglottic Airway Devices
• Interventions: Device: I-gel; Device: Self-pressurized air-Q

• Registration Number: NCT04365192
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).

The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.

The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.

The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.

The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-26
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 65-85 years old
• ASA I-III
• Elective urologic surgery
• Mallampati 1-2

Exclusion Criteria

• BMI>35kg/m2
• Operation time more than 2 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
I-gel	I-gel	-
Self-pressurized air-Q	Self-pressurized air-Q	-

Primary Outcome Measures

Name	Time	Method
Success in first attempt	3 minutes	Correct insertion was assessed by proper chest expansion, the presence of a CO2 wave form with a plateau on the capnograph, absence of audible leak, and lack of gastric insufflation.

Secondary Outcome Measures

Name	Time	Method
Fiberoptic view grade	4 minutes	Grade 1: whole vocal cords are seen, the epiglottis is not seen at all. Grade 2: larynx plus the posterior surface of epiglottis are seen. Grade 3: the anterior tip of the epiglottis is seen. Grade 4: the anterior tip of the epiglottis is seen and encroaching on the view of vocal cords obstructing \<50% of view. Grade 5: the epiglottis is completely obstructing the AQ opening, no view is seen.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey