Laryngeal Masks for Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Padova
Sponsor:
Collaborator:
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01724970
First received: September 14, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • total anesthetic and analgesic drug dosages [ Time Frame: intraoperatively and postoperatively, up to 24 hours from end of surgery ] [ Designated as safety issue: No ]
  • pulse oximetry saturation [ Time Frame: intraoperatively and postoperatively, up to 24 hours from end of surgery ] [ Designated as safety issue: Yes ]
  • time to post-anesthetic discharge scoring system (PADSS) > 8 [ Time Frame: in PACU up 72 hours ] [ Designated as safety issue: Yes ]
  • EKG monitoring [ Time Frame: postoperatively up to 72 hours ] [ Designated as safety issue: Yes ]
  • satisfaction of the surgeon (ad hoc questionnaire) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • gastric distension [ Time Frame: intraoperatively up to 3 hours ] [ Designated as safety issue: Yes ]
  • levels of pain and nausea (Visual Analogue Scale) [ Time Frame: postoperatively up to 24 hours ] [ Designated as safety issue: Yes ]
  • metilen's blue [ Time Frame: before end of surgery up to 3 hours ] [ Designated as safety issue: Yes ]
  • total dosage of analgesic and antihemetic drugs [ Time Frame: intra and postoperatively up to 24 hours ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • insertion time [ Time Frame: up to 10 minutes ] [ Designated as safety issue: Yes ]

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
ProSeal
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01724970

Contacts
Contact: Michele Carron, MD +39 049 821 3090 michele.carron@unipd.it
Contact: Ulderico Freo, MD +39 049 821 3090 ulderico.freo@unipd.it

Locations
Italy
University of Padua Recruiting
Padua, PD, Italy, 35121
Contact: Michele Carron, MD    +39 049 8211111 ext 3090    michele.carron@unipd.it   
Contact: Ulderico Freo, MD    +39 049 8211111 ext 3094    ulderico.freo@unipd.it   
Sponsors and Collaborators
University of Padova
Azienda Ospedaliera di Padova
Investigators
Principal Investigator: Michele Carron, MD Università di Padova
  More Information

No publications provided

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01724970     History of Changes
Other Study ID Numbers: 2276P
Study First Received: September 14, 2012
Last Updated: November 7, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Padova:
anesthesia
postanesthetic recovery
ventilation
bariatric surgery

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014