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

I

Istanbul Medeniyet University

Status

Completed

Conditions

Supraglottic Airway Devices

Treatments

Device: Self-pressurized air-Q
Device: I-gel

Study type

Observational

Funder types

Other

Identifiers

NCT04365192
2013-KAEK-64

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

I-gel
Treatment:
Device: I-gel
Self-pressurized air-Q
Treatment:
Device: Self-pressurized air-Q

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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