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Laryngeal Masks for Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724970
Recruitment Status : Unknown
Verified November 2012 by University of Padova.
Recruitment status was:  Recruiting
First Posted : November 12, 2012
Last Update Posted : November 12, 2012
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova

Brief Summary:
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: ProSeal Device: Supreme LMA Phase 3

Detailed Description:
The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PLMA
Device: ProSeal
Patients will be ventilated with PLMA

Experimental: SLMA
Supreme LMA
Device: Supreme LMA
Patients will be ventilated with SLMA

Primary Outcome Measures :
  1. oropharyngeal leak pressure [ Time Frame: intraoperatively, up to 3 hours ]

Secondary Outcome Measures :
  1. total anesthetic and analgesic drug dosages [ Time Frame: intraoperatively and postoperatively, up to 24 hours from end of surgery ]
  2. pulse oximetry saturation [ Time Frame: intraoperatively and postoperatively, up to 24 hours from end of surgery ]
  3. time to post-anesthetic discharge scoring system (PADSS) > 8 [ Time Frame: in PACU up 72 hours ]
  4. EKG monitoring [ Time Frame: postoperatively up to 72 hours ]
  5. satisfaction of the surgeon (ad hoc questionnaire) [ Time Frame: day 1 ]
  6. satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale) [ Time Frame: day 1 ]
  7. gastric distension [ Time Frame: intraoperatively up to 3 hours ]
  8. levels of pain and nausea (Visual Analogue Scale) [ Time Frame: postoperatively up to 24 hours ]
  9. metilen's blue [ Time Frame: before end of surgery up to 3 hours ]
  10. total dosage of analgesic and antihemetic drugs [ Time Frame: intra and postoperatively up to 24 hours ]

Other Outcome Measures:
  1. insertion time [ Time Frame: up to 10 minutes ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • ASA class I-III
  • candidates to bariatric surgery

Exclusion Criteria:

  • uncontrolled psychiatric symptomatology
  • known or presumed pregnancy
  • history of surgery on the airway or esophagus
  • gastroesophageal reflux

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 identifier (NCT number): NCT01724970

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Contact: Michele Carron, MD +39 049 821 3090
Contact: Ulderico Freo, MD +39 049 821 3090

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University of Padua Recruiting
Padua, PD, Italy, 35121
Contact: Michele Carron, MD    +39 049 8211111 ext 3090   
Contact: Ulderico Freo, MD    +39 049 8211111 ext 3094   
Sponsors and Collaborators
University of Padova
Azienda Ospedaliera di Padova
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Principal Investigator: Michele Carron, MD University of Padova
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Responsible Party: University of Padova Identifier: NCT01724970    
Other Study ID Numbers: 2276P
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012
Keywords provided by University of Padova:
postanesthetic recovery
bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight