Effectiveness of the New Perilaryngeal Airway in Comparison With the Laryngeal Mask Airway

NCT ID: NCT02439021

Last Updated: 2015-05-08

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

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CobraPLA

Patients will randomly assign to either LMA or Cobra PLATM

Group Type EXPERIMENTAL

COBRA

Intervention Type DEVICE

LMA

Patients will randomly assign to either LMA or Cobra PLATM

Group Type EXPERIMENTAL

LMA

Intervention Type DEVICE

Interventions

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COBRA

Intervention Type DEVICE

LMA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BMI between 25 to 35 kg/m2
* scheduled for surgery
* being older than 18 years
* Mallampati class I-III and BMI between 25 and 35

Exclusion Criteria

* pregnancy
* morbid obese (BMI\>35 kg/m2)
* a known difficult airway
* gastro-oesophageal reflux
* pharyngeal pathology
* emergency operation with full stomach
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir H Pakpour

Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir H Pakpour, PhD

Role: PRINCIPAL_INVESTIGATOR

Qazvin University Of Medical Sciences

Other Identifiers

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653

Identifier Type: -

Identifier Source: org_study_id

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