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

Not Applicable

Completed

• Conditions: General Anesthesia; Supraglottic Airway Devices
• Interventions: Device: Insertion of I-gel; Device: Insertion of air-Q

• Registration Number: NCT02140008
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-21
• Last Update Posted: 2014-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-gel group	Insertion of I-gel	-
Air-Q group	Insertion of air-Q	-

Primary Outcome Measures

Name	Time	Method
airway leak pressure	within 5 min after insertion of each device

Secondary Outcome Measures

Name	Time	Method
Insertion time (insertion parameter)	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.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of