Comparison of the LMA Protector and the I-gel

NCT ID: NCT03078517

Last Updated: 2018-02-05

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-01-20

Brief Summary

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Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.

Detailed Description

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Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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I-gel group

After the induction of anesthesia, I-gel is inserted into the oropharyngeal space.

Group Type ACTIVE_COMPARATOR

I-gel

Intervention Type DEVICE

After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.

LMA protector group

After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space.

Group Type EXPERIMENTAL

Laryngeal mask airway protector

Intervention Type DEVICE

After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

Interventions

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I-gel

After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.

Intervention Type DEVICE

Laryngeal mask airway protector

After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria

* Surgical position other than supine position
* Tumors or anatomical abnormalities in the upper airway
* Known or predicted difficult airway
* Body mass index \> 30 kg/m2
* Required postoperative mechanical ventilation
* Head and neck surgery
* Aspiration tendency
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Young Hwang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8.

Reference Type DERIVED
PMID: 31272379 (View on PubMed)

Other Identifiers

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20170104

Identifier Type: -

Identifier Source: org_study_id

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