NCT03933644

Brief Summary

The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA. It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP). The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA. The study also evaluates the OLP after 15 minutes and after 30 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 4, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

April 4, 2019

Last Update Submit

November 19, 2020

Conditions

Oropharyngeal Leak Pressure

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal Leak Pressure

    after insertion

    immediately after insertion

Secondary Outcomes (2)

  • Oropharyngeal Leak Pressure

    15 minutes

  • Oropharyngeal Leak Pressure

    30 minutes

Study Arms (2)

Ambu Aura Gain TM with gastric tube

OTHER
Device: Gastric Tube

Ambu Aura Gain TM without gastric tube

OTHER
Device: No gastric Tube

Interventions

Gastric TubeDEVICE

SGA is inserted with a gastric tube as guide for insertion

Ambu Aura Gain TM with gastric tube
No gastric TubeDEVICE

SGA is inserted without a gastric tube as guide for insertion

Ambu Aura Gain TM without gastric tube

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I - 3
  • Signed informed consent
  • Age 18 - 90 years
  • Edentolous (or partial) patients
  • Patients scheduled for elective surgery

You may not qualify if:

  • Patients with a known or predicted difficult airway
  • Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
  • Patients at risk for aspiration
  • Body mass index (BMI) \> 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUInnsbruck

Innsbruck, Austria

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Lukas Gasteiger, Dr

    Departement for Anaesthesia and Intensive Care - Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

May 1, 2019

Study Start

May 15, 2019

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)