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Laryngeal Mask in Morbid Obesity

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Supraglottic device (SGD)
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Morbid Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Padiua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PLMA

I-gel

Arm Description

The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.

The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.

Outcomes

Primary Outcome Measures

Oropharyngeal leak pressure (OLP)
OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD

Secondary Outcome Measures

Time insertion
Time for definitive placement of SGD
SGD placement
Ease of insertion of the SGD
Gastric tube
Ease of insertion of the gastric tube through the dedicated conduit
fiberoptic evaluation
Fiberoptic evaluation of correct positioning through SGD
Leak fraction
The leak fraction is defined as the leak volume divided by the inspired tidal volume.

Full Information

First Posted
January 24, 2020
Last Updated
April 28, 2021
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT04243564
Brief Title
Laryngeal Mask in Morbid Obesity
Official Title
Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. I

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLMA
Arm Type
Active Comparator
Arm Description
The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.
Arm Title
I-gel
Arm Type
Active Comparator
Arm Description
The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.
Intervention Type
Device
Intervention Name(s)
Supraglottic device (SGD)
Intervention Description
Positioning of SGD as temporary ventilatory device before tracheal intubation
Primary Outcome Measure Information:
Title
Oropharyngeal leak pressure (OLP)
Description
OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD
Time Frame
Procedure (After correct placement of SGD)
Secondary Outcome Measure Information:
Title
Time insertion
Description
Time for definitive placement of SGD
Time Frame
Procedure (Time from pick up to correct placement of SGD)
Title
SGD placement
Description
Ease of insertion of the SGD
Time Frame
Procedure (From pick up to correct placement of SGD)
Title
Gastric tube
Description
Ease of insertion of the gastric tube through the dedicated conduit
Time Frame
Procedure (After correct placement of SGD)
Title
fiberoptic evaluation
Description
Fiberoptic evaluation of correct positioning through SGD
Time Frame
Procedure (After correct placement of SGD and established ventilation)
Title
Leak fraction
Description
The leak fraction is defined as the leak volume divided by the inspired tidal volume.
Time Frame
Procedure (After correct placement of SGD and established ventilation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Carron, MD
Phone
0498213090
Ext
+39
Email
michele.carron@unipd.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Carron, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Padiua Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Carron, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20645948
Citation
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.
Results Reference
result
PubMed Identifier
11867408
Citation
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.
Results Reference
result
PubMed Identifier
22783708
Citation
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.
Results Reference
result
PubMed Identifier
27555181
Citation
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.
Results Reference
result

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Laryngeal Mask in Morbid Obesity

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