Laryngeal Mask in Morbid Obesity

Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients

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

Study Overview

• Status: Withdrawn
• Conditions: Morbid Obesity
• Intervention / Treatment: Device: Supraglottic device (SGD)

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.

I

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Carron, MD; Phone Number: +39 0498213090; Email: michele.carron@unipd.it

Study Locations

• Italy
  • Padova, Italy, 35128
    • University Padiua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PLMA; The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.	Device: Supraglottic device (SGD); Positioning of SGD as temporary ventilatory device before tracheal intubation
Active Comparator: I-gel; The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.	Device: Supraglottic device (SGD); Positioning of SGD as temporary ventilatory device before tracheal intubation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Michele Carron, MD, University of Padova

Publications and helpful links

General Publications

• Gasteiger L, Brimacombe J, Perkhofer D, Kaufmann M, Keller C. Comparison of guided insertion of the LMA ProSeal vs the i-gel. Anaesthesia. 2010 Sep;65(9):913-6. doi: 10.1111/j.1365-2044.2010.06422.x.
• Keller C, Brimacombe J, Kleinsasser A, Brimacombe L. The Laryngeal Mask Airway ProSeal(TM) as a temporary ventilatory device in grossly and morbidly obese patients before laryngoscope-guided tracheal intubation. Anesth Analg. 2002 Mar;94(3):737-40; table of contents. doi: 10.1097/00000539-200203000-00048.
• Van Zundert TC, Brimacombe JR. Similar oropharyngeal leak pressures during anaesthesia with i-gel, LMA-ProSeal and LMA-Supreme Laryngeal Masks. Acta Anaesthesiol Belg. 2012;63(1):35-41.
• Maitra S, Baidya DK, Arora MK, Bhattacharjee S, Khanna P. Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin Anesth. 2016 Sep;33:298-305. doi: 10.1016/j.jclinane.2016.04.020. Epub 2016 May 18.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): March 15, 2022
• Study Completion (Estimated): June 15, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 3793AO16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No