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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Supraglottic Airway Devices
• Intervention / Treatment: Device: Insertion of I-gel; Device: Insertion of air-Q

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-gel group	Device: Insertion of I-gel; After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.
Active Comparator: Air-Q group	Device: Insertion of air-Q; After induction of general anesthesia, air-Q was inserted according to randomly allocated group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
airway leak pressure	within 5 min after insertion of each device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion (insertion parameter)	Ease of insertion was graded from 1 to 4	During and 1 min after insertion of each device

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 21, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: children; supraglottic airway devices; the i-gel; the self-pressurised air-Q intubating laryngeal airway,
• Other Study ID Numbers: 1-2014-0011