Laryngeal Masks for Bariatric Surgery

University of Padova

Status and phase: Unknown; Phase 3

Conditions: Morbid Obesity

Treatments: Device: Supreme LMA; Device: ProSeal

Study type: Interventional

Funder types: Other

Identifiers

NCT01724970

2276P

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

PLMA

Experimental group

Description:

ProSeal

Treatment:

Device: ProSeal

SLMA

Experimental group

Description:

Supreme LMA

Treatment:

Device: Supreme LMA