Back to resultsLaryngeal Masks for Bariatric Surgery
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ProSeal
Supreme LMA
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring anesthesia, postanesthetic recovery, ventilation, bariatric surgery
Eligibility 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
Sites / Locations
- University of PaduaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PLMA
SLMA
Arm Description
ProSeal
Supreme LMA
Outcomes
Primary Outcome Measures
oropharyngeal leak pressure
Secondary Outcome Measures
total anesthetic and analgesic drug dosages
pulse oximetry saturation
time to post-anesthetic discharge scoring system (PADSS) > 8
EKG monitoring
satisfaction of the surgeon (ad hoc questionnaire)
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
gastric distension
levels of pain and nausea (Visual Analogue Scale)
metilen's blue
total dosage of analgesic and antihemetic drugs
Full Information
NCT ID
NCT01724970
First Posted
September 14, 2012
Last Updated
November 7, 2012
Sponsor
University of Padova
Collaborators
Azienda Ospedaliera di Padova
1. Study Identification
Unique Protocol Identification Number
NCT01724970
Brief Title
Laryngeal Masks for Bariatric Surgery
Official Title
A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
Collaborators
Azienda Ospedaliera di Padova
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
anesthesia, postanesthetic recovery, ventilation, bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PLMA
Arm Type
Experimental
Arm Description
ProSeal
Arm Title
SLMA
Arm Type
Experimental
Arm Description
Supreme LMA
Intervention Type
Device
Intervention Name(s)
ProSeal
Intervention Description
Patients will be ventilated with PLMA
Intervention Type
Device
Intervention Name(s)
Supreme LMA
Intervention Description
Patients will be ventilated with SLMA
Primary Outcome Measure Information:
Title
oropharyngeal leak pressure
Time Frame
intraoperatively, up to 3 hours
Secondary Outcome Measure Information:
Title
total anesthetic and analgesic drug dosages
Time Frame
intraoperatively and postoperatively, up to 24 hours from end of surgery
Title
pulse oximetry saturation
Time Frame
intraoperatively and postoperatively, up to 24 hours from end of surgery
Title
time to post-anesthetic discharge scoring system (PADSS) > 8
Time Frame
in PACU up 72 hours
Title
EKG monitoring
Time Frame
postoperatively up to 72 hours
Title
satisfaction of the surgeon (ad hoc questionnaire)
Time Frame
day 1
Title
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
Time Frame
day 1
Title
gastric distension
Time Frame
intraoperatively up to 3 hours
Title
levels of pain and nausea (Visual Analogue Scale)
Time Frame
postoperatively up to 24 hours
Title
metilen's blue
Time Frame
before end of surgery up to 3 hours
Title
total dosage of analgesic and antihemetic drugs
Time Frame
intra and postoperatively up to 24 hours
Other Pre-specified Outcome Measures:
Title
insertion time
Time Frame
up to 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Carron, MD
Phone
+39 049 821 3090
Email
michele.carron@unipd.it
First Name & Middle Initial & Last Name or Official Title & Degree
Ulderico Freo, MD
Phone
+39 049 821 3090
Email
ulderico.freo@unipd.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Carron, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Padua
City
Padua
State/Province
PD
ZIP/Postal Code
35121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Carron, MD
Phone
+39 049 8211111
Ext
3090
Email
michele.carron@unipd.it
First Name & Middle Initial & Last Name & Degree
Ulderico Freo, MD
Phone
+39 049 8211111
Ext
3094
Email
ulderico.freo@unipd.it
12. IPD Sharing Statement
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Laryngeal Masks for Bariatric Surgery
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