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ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients

NCT ID: NCT01184677

Last Updated: 2012-08-27

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

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-02-29

Brief Summary

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The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.

Detailed Description

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The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood.

The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.

Conditions

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Oropharyngeal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group size 4

Group Type PLACEBO_COMPARATOR

insertion of the PLMA

Intervention Type DEVICE

ProSeal LMA size 4 is inserted to the patients of Group size 4.

Group size 3

ProSeal LMA size 3 is inserted to the patients of Group size 3.

Group Type EXPERIMENTAL

insertion of the ProSeal LMA (PLMA)

Intervention Type DEVICE

ProSeal LMA size 3 is inserted to the patients of Group size 3.

Interventions

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insertion of the ProSeal LMA (PLMA)

ProSeal LMA size 3 is inserted to the patients of Group size 3.

Intervention Type DEVICE

insertion of the PLMA

ProSeal LMA size 4 is inserted to the patients of Group size 4.

Intervention Type DEVICE

Other Intervention Names

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insertion ProSeal LMA size 3 insertion ProSeal LMA size 4

Eligibility Criteria

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Inclusion Criteria

* female
* aged 18-80 yr
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia

Exclusion Criteria

* a known or predicted difficult airway
* recent sore throat
* mouth opening less than 2.5 cm
* body mass index \> 35 kg/m2
* at risk of aspiration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Mihyun

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mihyun Kim, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ProSeal LMA 3 vs 4

Identifier Type: -

Identifier Source: org_study_id