A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients

NCT ID: NCT02260427

Last Updated: 2016-09-07

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-08-31

Brief Summary

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Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) 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 similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients

Detailed Description

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Conditions

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Supraglottic Airway Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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the i-gel group

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

Group Type EXPERIMENTAL

Insertion of the i-gel

Intervention Type DEVICE

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

the Air-Q sp group

After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.

Group Type ACTIVE_COMPARATOR

Insertion of the air-Q sp

Intervention Type DEVICE

Interventions

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Insertion of the i-gel

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

Intervention Type DEVICE

Insertion of the air-Q sp

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway

Exclusion Criteria

1\. Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 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

Principal Investigators

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Min-Soo Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul

Locations

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Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.

Reference Type DERIVED
PMID: 30320644 (View on PubMed)

Other Identifiers

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3-2014-0157

Identifier Type: -

Identifier Source: org_study_id

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