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Laryngeal Mask in Morbid Obesity

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ClinicalTrials.gov Identifier: NCT04243564
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Supraglottic device (SGD) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients
Estimated Study Start Date : February 17, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

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




Primary Outcome Measures :
  1. Oropharyngeal leak pressure (OLP) [ Time Frame: 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 :
  1. Time insertion [ Time Frame: Procedure (Time from pick up to correct placement of SGD) ]
    Time for definitive placement of SGD

  2. SGD placement [ Time Frame: Procedure (From pick up to correct placement of SGD) ]
    Ease of insertion of the SGD

  3. Gastric tube [ Time Frame: Procedure (After correct placement of SGD) ]
    Ease of insertion of the gastric tube through the dedicated conduit

  4. fiberoptic evaluation [ Time Frame: Procedure (After correct placement of SGD and established ventilation) ]
    Fiberoptic evaluation of correct positioning through SGD

  5. Leak fraction [ Time Frame: Procedure (After correct placement of SGD and established ventilation) ]
    The leak fraction is defined as the leak volume divided by the inspired tidal volume.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243564


Contacts
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Contact: Michele Carron, MD 0498213090 ext +39 michele.carron@unipd.it

Sponsors and Collaborators
University of Padova
Investigators
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Principal Investigator: Michele Carron, MD University of Padova

Publications of Results:
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT04243564    
Other Study ID Numbers: 3793AO16
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms