Laryngeal Mask in Morbid Obesity

Not Applicable

Withdrawn

• Conditions: Morbid Obesity
• Interventions: Device: Supraglottic device (SGD)

• Registration Number: NCT04243564
• Lead Sponsor: University of Padova

Brief Summary

Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients

Detailed Description

The available data regarding SGDs in morbidly obese patients have focused mainly on PLMA. In general, SGDs have been successfully used as temporary ventilatory devices before laryngoscope-guided tracheal intubation, conduits for endotracheal tube insertion, and primary airway devices during surgery. Second-generation SGDs are preferred for both rescue airway and routine use, compared with first-generation, non-gastric access devices. Data on comparison PLMA vs. I-gel in morbidly obese patient are lacking.

The PLMA is a second generation gastric access SGD. PLMA is composed of an airway tube that connects to a mask which, after insertion through the patient's mouth and inflation of cuff, forms an airtight seal on top the glottis allowing a secure airway to be managed by a health care provider. PLMA can be autoclaved and reused many times. I-gel is a new type of single use, second generation, gastric access SGD and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage.

The aim of this study is to compare PLMA and I-gel regarding insertion success rate, the time of insertion, gastric access tube positioning, oropharyngeal leak pressure, assessment of position by fiberoptic, ventilatory parameters and hemodynamic, and complications for each device placed before tracheal intubation in morbidly obese patients.

This study is conducted at University Medical Hospital of Padova, with approval from Hospital research Ethical Committee and written informed consents from patients,. Patients are randomly allocated into 2 equal groups, according to the inclusion and exclusion criteria.

PLMA (n=35) in which PLMA is used for ventilation. I-gel (n=35) in which I-gel is used for ventilation.

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Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Status Verified: 2021-01
• Study Start: 2021-02-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-06-15
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• morbidly obese patients scheduled for elective bariatric surgery under general anesthesia

Exclusion Criteria

• nonfasting; symptoms or endoscopic evidence of gastroesophageal reflux, of gastric ulcer, or oropharyngeal pathology; known or predicted difficult airway; allergy to anesthetic and nonsteroidal antiinflammatory drugs; or inability to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLMA	Supraglottic device (SGD)	The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.
I-gel	Supraglottic device (SGD)	The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure (OLP)	Procedure (After correct placement of SGD)	OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD

Secondary Outcome Measures

Name	Time	Method
SGD placement	Procedure (From pick up to correct placement of SGD)	Ease of insertion of the SGD
fiberoptic evaluation	Procedure (After correct placement of SGD and established ventilation)	Fiberoptic evaluation of correct positioning through SGD
Gastric tube	Procedure (After correct placement of SGD)	Ease of insertion of the gastric tube through the dedicated conduit
Time insertion	Procedure (Time from pick up to correct placement of SGD)	Time for definitive placement of SGD
Leak fraction	Procedure (After correct placement of SGD and established ventilation)	The leak fraction is defined as the leak volume divided by the inspired tidal volume.

Trial Locations

Locations (1)

University Padiua Hospital; 🇮🇹 Padova, Italy