This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Laryngeal Masks for Bariatric Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by University of Padova.
Recruitment status was:  Recruiting
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova Identifier:
First received: September 14, 2012
Last updated: November 7, 2012
Last verified: November 2012
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 Intervention Phase
Morbid Obesity Device: ProSeal Device: Supreme LMA Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.

Resource links provided by NLM:

Further study details as provided by University of Padova:

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

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

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

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLMA
Device: ProSeal
Patients will be ventilated with PLMA
Experimental: SLMA
Supreme LMA
Device: Supreme LMA
Patients will be ventilated with SLMA

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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01724970

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

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
Principal Investigator: Michele Carron, MD Università di Padova
  More Information

Responsible Party: University of Padova Identifier: NCT01724970     History of Changes
Other Study ID Numbers: 2276P
Study First Received: September 14, 2012
Last Updated: November 7, 2012

Keywords provided by University of Padova:
postanesthetic recovery
bariatric surgery

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on August 16, 2017