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

Supraglottic Airway Devices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365192
• Other study ID #: 2013-KAEK-64
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2020
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Supraglottic Airway Devices

Intervention

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
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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