NCT03108391

Brief Summary

The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

March 14, 2017

Last Update Submit

April 11, 2017

Conditions

Supraglottic Airway

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure

    The airway pressure at which an airway leak is observed after successful placement of the device

    Up to 1 minute after the time of confirmed device placement

Secondary Outcomes (4)

  • Insertion time

    Up to 1 minute on each insertion attempt

  • Ease of insertion

    Up to 1 minute on each insertion attempt

  • Fiberoptic Grade of Laryngeal View

    Up to 1 minute after placement of device

  • Postoperative Complications

    2 hours after removal of the device

Study Arms (2)

Ambu AuraGain

EXPERIMENTAL

Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines

Device: Ambu AuraGain

LMA Supreme

ACTIVE COMPARATOR

Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines

Device: LMA Supreme

Interventions

Ambu AuraGainDEVICE
Ambu AuraGain
LMA SupremeDEVICE
LMA Supreme

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists Ⅰ-Ⅲ classification
  • Patients evaluated as eligible for a LMA
  • Body Mass Index ≤35kg/m2

You may not qualify if:

  • Patients with known or predicted difficult airway
  • Active respiratory infection
  • Risk of aspiration
  • Head and neck surgery
  • Emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChineseAMS

Beijing, Beijing Municipality, 100144, China

RECRUITING

Study Officials

  • Liu Juhui, MD

    Plastic Surgery Hospital, ChineseAMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Juhui, MD

CONTACT

+8615210258001liujuhui2006@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parellel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgery Hospital

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 11, 2017

Study Start

January 1, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

CN(1)