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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03933644

Recruitment Status Completed

First Posted May 1, 2019

Last update posted November 23, 2020

Study Description

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.

  • Condition or Disease:Oropharyngeal Leak Pressure
  • Intervention/Treatment: Device: Gastric Tube
    Device: No gastric Tube
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 70 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Other: Ambu Aura Gain TM with gastric tube
Device: Gastric Tube
SGA is inserted with a gastric tube as guide for insertion
Other: Ambu Aura Gain TM without gastric tube
Device: No gastric Tube
SGA is inserted without a gastric tube as guide for insertion
Outcome Measures
  • Primary Outcome Measures: 1. Oropharyngeal Leak Pressure [ Time Frame: immediately after insertion ]
    after insertion
  • Secondary Outcome Measures: 1. Oropharyngeal Leak Pressure [ Time Frame: 15 minutes ]
    after 15 minutes
  • 2. Oropharyngeal Leak Pressure [ Time Frame: 30 minutes ]
    after 30 minutes
Eligibility Criteria
  • Ages Eligible for Study: 18 to 90 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

Austria
MUInnsbruck
Innsbruck

Sponsors and Collaborators

Medical University Innsbruck

Investigators

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

More Information
  • Responsible Party: Medical University Innsbruck
  • ClinicalTrials.gov Identifier: NCT03933644 History of Changes
  • Other Study ID Numbers: Zahnlos
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: November 23, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No