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

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140008
• Other study ID #: 1-2014-0011
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: September 21, 2014
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 108 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• General Anesthesia
• Supraglottic Airway Devices

Intervention

Device:
• Insertion of I-gel
After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.
• Insertion of air-Q
After induction of general anesthesia, air-Q was inserted according to randomly allocated group.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ease of insertion (insertion parameter)	Ease of insertion was graded from 1 to 4	During and 1 min after insertion of each device	No
Primary	airway leak pressure		within 5 min after insertion of each device	No
Secondary	Insertion time (insertion parameter)	insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.	During and 1 min after insertion of each device	No