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OpenTrials
Completed

NCT Number: NCT02140008

A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children

Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.

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Key information

Conditions

General Anesthesia Supraglottic Airway Devices

Age range

1 month–108 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) 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 I-gel

Device

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

Insertion of air-Q

Device

After induction of general anesthesia, air-Q was inserted according to randomly allocated group.

Primary outcomes

  1. airway leak pressure

    Time frame: within 5 min after insertion of each device

Secondary outcomes

  1. Insertion time (insertion parameter)

    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.

Other outcomes

  1. Ease of insertion (insertion parameter)

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

    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
2014
Study completion
2014
First posted
May 16, 2014
Registry last updated
Sep 23, 2014

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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