NCT02097771

Brief Summary

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

8 months

First QC Date

March 21, 2014

Last Update Submit

November 18, 2014

Conditions

Gastric Insufflation

Keywords

laryngeal mask airway ventilation

Outcome Measures

Primary Outcomes (1)

  • incidence of gastric insufflation

    during pulmonary ventilation through the laryngeal mask airway

Study Arms (2)

LMA SupremeTM

ACTIVE COMPARATOR
Device: LMA SupremeTM

Ambu AuraOnce

SHAM COMPARATOR
Device: AuraOnceTM

Interventions

LMA SupremeTMDEVICE
LMA SupremeTM
AuraOnceTMDEVICE
Ambu AuraOnce

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

Central Study Contacts

Lionel Bouvet

CONTACT

+33 4 72 11 69 88lionel.bouvet@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 27, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

FR(1)