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Laryngeal Masks for Bariatric Surgery

NCT ID: NCT01724970

Last Updated: 2012-11-12

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

Detailed Description

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The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Conditions

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Morbid Obesity

Keywords

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anesthesia postanesthetic recovery ventilation bariatric surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PLMA

ProSeal

Group Type EXPERIMENTAL

ProSeal

Intervention Type DEVICE

Patients will be ventilated with PLMA

SLMA

Supreme LMA

Group Type EXPERIMENTAL

Supreme LMA

Intervention Type DEVICE

Patients will be ventilated with SLMA

Interventions

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ProSeal

Patients will be ventilated with PLMA

Intervention Type DEVICE

Supreme LMA

Patients will be ventilated with SLMA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA class I-III
* candidates to bariatric surgery

Exclusion Criteria

* uncontrolled psychiatric symptomatology
* known or presumed pregnancy
* history of surgery on the airway or esophagus
* gastroesophageal reflux
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Padova

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele Carron, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

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University of Padua

Padua, PD, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Michele Carron, MD

Role: CONTACT

Phone: +39 049 821 3090

Email: [email protected]

Ulderico Freo, MD

Role: CONTACT

Phone: +39 049 821 3090

Email: [email protected]

Facility Contacts

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Michele Carron, MD

Role: primary

Ulderico Freo, MD

Role: backup

Other Identifiers

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2276P

Identifier Type: -

Identifier Source: org_study_id