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Completed

NCT Number: NCT02260427

A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients

Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients

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Key information

Conditions

Supraglottic Airway Device

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu

Seoul, 135-720, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway

Exclusion criteria

  • Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

Treatment and study plan

Insertion of the i-gel

Device

After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.

Insertion of the air-Q sp

Device

Primary outcomes

  1. airway leak pressure measured after device insertion

    Time frame: within 5min after insertion of each device

    Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Secondary outcomes

  1. insertion parameters (insertion time and ease of insertion)

    Time frame: During and 1 min after insertion of each device

    Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography. Ease of insertion was graded from 1 to 4.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2014
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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