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

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.

Study Overview

• Status: Completed
• Conditions: Supraglottic Airway Devices
• Intervention / Treatment: Device: I-gel; Device: Self-pressurized air-Q

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34722
    • İstanbul medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 83 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

65-85 years old patients who undergo urologic surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
I-gel	Device: I-gel; The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. 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.
Self-pressurized air-Q	Device: Self-pressurized air-Q; The self-pressured air-Q is a supraglottic airway management device 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success in first attempt	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.	3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiberoptic view grade	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.	4 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2013-KAEK-64

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No