Laryngeal Masks for Bariatric Surgery | NCT01724970

Studies
Laryngeal Masks for Bariatric Surgery

NCT01724970

Sponsor

University of Padova

Status

Unknown status

Last Update Posted

Nov 12, 2012Estimated

Enrollment

80Estimated

Phase

Phase 3

Conditions

Morbid Obesity

Interventions

ProSeal
Supreme LMA

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Sep 14, 2012

First Submission Date that Met QC Criteria

Nov 7, 2012

First Posted Date

Nov 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2012

Last Update Posted Date

Nov 12, 2012Estimated

Name	Class
Azienda Ospedaliera di Padova	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PLMA	Experimental	ProSeal	Device: ProSeal
SLMA	Experimental	Supreme LMA	Device: Supreme LMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProSeal	Device	Patients will be ventilated with PLMA	PLMA
Supreme LMA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
total anesthetic and analgesic drug dosages		intraoperatively and postoperatively, up to 24 hours from end of surgery
pulse oximetry saturation		intraoperatively and postoperatively, up to 24 hours from end of surgery

Other Outcomes

Measure	Description	Time Frame
insertion time		up to 10 minutes

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michele Carron, MD	Contact	+39 049 821 3090		michele.carron@unipd.it
Ulderico Freo, MD	Contact	+39 049 821 3090		ulderico.freo@unipd.it

Overall Officials

Name	Affiliation	Role
Michele Carron, MD	University of Padova	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Padua	Recruiting	Padua	PD	35121	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided