Laryngeal Masks for Bariatric Surgery

November 7, 2012 updated by: University of Padova

A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PD
      • Padua, PD, Italy, 35121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLMA
ProSeal
Device: ProSeal
Patients will be ventilated with PLMA
Experimental: SLMA
Supreme LMA
Device: Supreme LMA
Patients will be ventilated with SLMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oropharyngeal leak pressure
Time Frame: intraoperatively, up to 3 hours
intraoperatively, up to 3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
total anesthetic and analgesic drug dosages
Time Frame: intraoperatively and postoperatively, up to 24 hours from end of surgery
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
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
in PACU up 72 hours
EKG monitoring
Time Frame: postoperatively up to 72 hours
postoperatively up to 72 hours
satisfaction of the surgeon (ad hoc questionnaire)
Time Frame: day 1
day 1
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
Time Frame: day 1
day 1
gastric distension
Time Frame: intraoperatively up to 3 hours
intraoperatively up to 3 hours
levels of pain and nausea (Visual Analogue Scale)
Time Frame: postoperatively up to 24 hours
postoperatively up to 24 hours
metilen's blue
Time Frame: before end of surgery up to 3 hours
before end of surgery up to 3 hours
total dosage of analgesic and antihemetic drugs
Time Frame: intra and postoperatively up to 24 hours
intra and postoperatively up to 24 hours

Other Outcome Measures

Outcome Measure
Time Frame
insertion time
Time Frame: up to 10 minutes
up to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: Michele Carron, MD, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2276P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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