Supreme LMA and Proseal LMA in Prone Anesthetized Patient

NCT ID: NCT01814306

Last Updated: 2013-03-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

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There is no significant difference about success rate of two devices.

Detailed Description

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There is no significant difference about success rate of two device: efficacy and safety

Conditions

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Inadequate or Impaired Breathing Pattern or Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supreme

Supreme LMA

Group Type ACTIVE_COMPARATOR

Supreme LMA

Intervention Type DEVICE

Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion

Proseal

Proseal LMA

Group Type ACTIVE_COMPARATOR

Proseal LMA

Intervention Type DEVICE

Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion

Interventions

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Supreme LMA

Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion

Intervention Type DEVICE

Proseal LMA

Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society Anesthesiologists physical status I-III
* Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria

* Age \<15year
* Non-fast
* Morbid obesity (BMI \> 35kg/m2)
* Pregnancy
* Known or predicted difficult airway
* GERD
* History of laryngeal problem (injury,subglottic stenosis)
* Local pharyngeal problem (abscess,tumor)
* Poor dentation
* Pulmonary disease
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Chatchai Prechawai

Anesthesiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chatchai Prechawai

Role: STUDY_CHAIR

Prince of Songkla University

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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SPLMA-100-CPrechawai

Identifier Type: REGISTRY

Identifier Source: secondary_id

SPLMA-100

Identifier Type: -

Identifier Source: org_study_id

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