Gastric Insufflation and Laryngeal Mask Airway | NCT02097771

Studies
Gastric Insufflation and Laryngeal Mask Airway

NCT02097771

Sponsor

Lionel Bouvet

Status

Unknown status

Last Update Posted

Nov 19, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Gastric Insufflation

Interventions

LMA SupremeTM
AuraOnceTM

Countries

France

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 2014

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

Nov 2014

Primary Completion Date

Jul 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 21, 2014

First Submission Date that Met QC Criteria

Mar 24, 2014

First Posted Date

Mar 27, 2014Estimated

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 18, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Description Module

Brief Summary

Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LMA SupremeTM	Active Comparator		Device: LMA SupremeTM
Ambu AuraOnce	Sham Comparator		Device: AuraOnceTM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMA SupremeTM	Device		LMA SupremeTM
AuraOnceTM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of gastric insufflation		during pulmonary ventilation through the laryngeal mask airway

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1 or 2
Age > 18 yrs
Use of laryngeal mask airway required

Exclusion Criteria:

risk of pulmonary aspiration of gastric contents
Contraindication for the use of laryngeal mask airway
Tracheal intubation required
Patient's refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lionel Bouvet	Contact	+33 4 72 11 69 88		lionel.bouvet@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon	Recruiting	Lyon		69003	France