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

NCT ID: NCT02140008

Last Updated: 2014-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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General Anesthesia Supraglottic Airway Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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I-gel group

Group Type EXPERIMENTAL

Insertion of I-gel

Intervention Type DEVICE

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

Air-Q group

Group Type ACTIVE_COMPARATOR

Insertion of air-Q

Intervention Type DEVICE

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

Interventions

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Insertion of I-gel

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

Intervention Type DEVICE

Insertion of air-Q

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

108 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2014-0011

Identifier Type: -

Identifier Source: org_study_id

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