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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02140008
Enrollment
80
Registered
2014-05-16
Start date
2014-05-31
Completion date
2014-08-31
Last updated
2014-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Supraglottic Airway Devices

Keywords

supraglottic airway devices, the i-gel, the self-pressurised air-Q intubating laryngeal airway,, children

Brief summary

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.

Interventions

DEVICEInsertion of I-gel

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

DEVICEInsertion of air-Q

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 108 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
airway leak pressurewithin 5 min after insertion of each device

Secondary

MeasureTime frameDescription
Insertion time (insertion parameter)During and 1 min after insertion of each deviceinsertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.

Other

MeasureTime frameDescription
Ease of insertion (insertion parameter)During and 1 min after insertion of each deviceEase of insertion was graded from 1 to 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026