The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)

NCT ID: NCT02206438

Last Updated: 2019-01-11

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing 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 classic LMA and the air-Q SP.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1)C-LMA group

Group Type EXPERIMENTAL

Insertion of C-LMA

Intervention Type DEVICE

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

2)Air-Q group

Group Type ACTIVE_COMPARATOR

Insertion of air-Q according

Intervention Type DEVICE

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

Interventions

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Insertion of C-LMA

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

Intervention Type DEVICE

Insertion of air-Q according

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (20-75 of age) 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

20 Years

Maximum Eligible Age

75 Years

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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Human research Protection Center, Gangnam Severance Hospital,

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Ha SH, Kim MS, Suh J, Lee JS. Self-pressurized air-Q(R) intubating laryngeal airway versus the LMA(R) Classic: a randomized clinical trial. Can J Anaesth. 2018 May;65(5):543-550. doi: 10.1007/s12630-018-1082-6. Epub 2018 Feb 6.

Reference Type DERIVED
PMID: 29524199 (View on PubMed)

Other Identifiers

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3-2014-0081

Identifier Type: -

Identifier Source: org_study_id

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