Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu... | NCT03933644

Studies
Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

NCT03933644

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Nov 23, 2020Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Oropharyngeal Leak Pressure

Interventions

Gastric Tube
No gastric Tube

Countries

Austria

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 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2019Actual

Primary Completion Date

Feb 12, 2020Actual

Completion Date

Feb 12, 2020Actual

First Submitted Date

Apr 4, 2019

First Submission Date that Met QC Criteria

Apr 29, 2019

First Posted Date

May 1, 2019Actual

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 19, 2020

Last Update Posted Date

Nov 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ambu Aura Gain TM with gastric tube	Other		Device: Gastric Tube
Ambu Aura Gain TM without gastric tube	Other		Device: No gastric Tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric Tube	Device	SGA is inserted with a gastric tube as guide for insertion	Ambu Aura Gain TM with gastric tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oropharyngeal Leak Pressure	after insertion	immediately after insertion

Secondary Outcomes

Measure	Description	Time Frame
Oropharyngeal Leak Pressure	after 15 minutes	15 minutes
Oropharyngeal Leak Pressure	after 30 minutes	30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lukas Gasteiger, Dr	Departement for Anaesthesia and Intensive Care - Medical University Innsbruck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUInnsbruck		Innsbruck			Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided