Oropharyngeal Leak PressureNCT03933644
Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
A study testing Gastric Tube and No gastric Tube in people with Oropharyngeal Leak Pressure, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Leak Pressure
- What is being tested?
- Gastric Tube and No gastric Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 15 May 2019to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I - 3
- Signed informed consent
- Age 18 - 90 years
- Edentolous (or partial) patients
- Patients scheduled for elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
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.
- Conditions
- Oropharyngeal Leak Pressure
- Being tested
- Gastric Tube, No gastric Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric TubeDevice
SGA is inserted with a gastric tube as guide for insertion
No gastric TubeDevice
SGA is inserted without a gastric tube as guide for insertion
| Study group | Role | What they receive |
|---|---|---|
| Ambu Aura Gain TM with gastric tube | Other | Not described Receives: Device: Gastric Tube |
| Ambu Aura Gain TM without gastric tube | Other | Not described Receives: Device: No gastric Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Leak Pressure
after insertion
Measured: immediately after insertion
Secondary outcomes (2)
Oropharyngeal Leak Pressure
after 15 minutes
Measured: 15 minutes
Oropharyngeal Leak Pressure
after 30 minutes
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start15 May 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Leak PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Gasteiger, Dr, Principal investigator, Departement for Anaesthesia and Intensive Care - Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933644
- Sponsor's protocol ID
- Zahnlos
- Status last verified
- Nov 2020
- First submitted
- 4 Apr 2019
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
- ClinicalTrials.gov ID
- NCT03933644
- Acronym / sponsor ID
- Zahnlos
- Conditions
- Oropharyngeal Leak Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu Aura Gain TM with gastric tube | Other | Device: Gastric Tube |
| Ambu Aura Gain TM without gastric tube | Other | Device: No gastric Tube |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I - 3
- Signed informed consent
- Age 18 - 90 years
- Edentolous (or partial) patients
- Patients scheduled for elective surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric TubeSGA is inserted with a gastric tube as guide for insertion | Device | Ambu Aura Gain TM with gastric tube |
| No gastric TubeSGA is inserted without a gastric tube as guide for insertion | Device | Ambu Aura Gain TM without gastric tube |
Primary outcome
Oropharyngeal Leak Pressure
Time frame: immediately after insertion
after insertion
2 secondary outcomes
Oropharyngeal Leak Pressure
Time frame: 15 minutes
Oropharyngeal Leak Pressure
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Oropharyngeal Leak Pressure
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Recruiting
Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients
Elderly (People Aged 65 or More), LMA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Gasteiger, Dr principal investigator
Departement for Anaesthesia and Intensive Care - Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Tube and No gastric Tube in people with Oropharyngeal Leak Pressure, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal Leak Pressure (time frame: immediately after insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020; AzTrials last refreshed its copy on 1 Nov 2026.