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

NCT02140008 | Completed DMC

• 1 other identifier: 1-2014-0011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Supraglottic Airway Devices

Keywords

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

Outcome Measures

Primary Outcomes (1)

• airway leak pressure

  within 5 min after insertion of each device

Secondary Outcomes (1)

• Insertion time (insertion parameter)

  During and 1 min after insertion of each device

Other Outcomes (1)

• Ease of insertion (insertion parameter)

  During and 1 min after insertion of each device

Study Arms (2)

I-gel group

EXPERIMENTAL

Device: Insertion of I-gel

Air-Q group

ACTIVE COMPARATOR

Device: Insertion of air-Q

Interventions

Insertion of I-gel DEVICE

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

I-gel group

Insertion of air-Q DEVICE

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

Air-Q group

Eligibility Criteria

• Age: 1 Month - 108 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 23, 2014

Record last verified: 2014-09

Locations

KR (1)