Laryngeal Mask in Morbid Obesity
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- Time insertion [Procedure (Time from pick up to correct placement of SGD)]
Time for definitive placement of SGD
- SGD placement [Procedure (From pick up to correct placement of SGD)]
Ease of insertion of the SGD
- Gastric tube [Procedure (After correct placement of SGD)]
Ease of insertion of the gastric tube through the dedicated conduit
- fiberoptic evaluation [Procedure (After correct placement of SGD and established ventilation)]
Fiberoptic evaluation of correct positioning through 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Padiua Hospital | Padova | Italy | 35128 |
Sponsors and Collaborators
- University of Padova
Investigators
- Principal Investigator: Michele Carron, MD, University of Padova
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3793AO16