Airway ManagementNCT02811042
Ambu AuraOnce Versus Ambu AuraGain LM in Children
A study testing Ambu AuraOnce and Ambu AuraGain in people with Airway Management, run by Schulthess Klinik at 2 sites in 2 countries.
Trial summary
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Ambu AuraOnce and Ambu AuraGain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2016to Mar 2017
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II
- age 1 - 16 years
- minor surgery
- extraglottic airway device
Who cannot join
- age (<12 months, >16 years)
- weight (<12 kg, >50 kg)
- a known difficult airway
- risk of aspiration
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.
- Conditions
- Airway Management
- Being tested
- Ambu AuraOnce, Ambu AuraGain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuraOnceDevice
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
Ambu AuraGainDevice
The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal leak pressure | Active comparator | Ambu AuraOnce Receives: Device: Ambu AuraOnce |
| Fiberoptic position | Experimental | Ambu AuraGain Receives: Device: Ambu AuraGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
oropharyngeal leak pressure
Measured: 5 min
Secondary outcomes (1)
fiberoptic position
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salzburg
- Responsible party
- Principal investigator, ChristianKeller, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811042
- Sponsor's protocol ID
- Schulthess_Anä_7
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stogermuller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu(R) Aura Gain versus Ambu(R) Aura Once in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.
PubMed 30315506
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position
- ClinicalTrials.gov ID
- NCT02811042
- Acronym / sponsor ID
- Schulthess_Anä_7
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- University of Salzburg
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- 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 investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal leak pressure | Active comparator | Device: Ambu AuraOnceAmbu AuraOnce |
| Fiberoptic position | Experimental | Device: Ambu AuraGainAmbu AuraGain |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA I-II
- age 1 - 16 years
- minor surgery
- extraglottic airway device
Key exclusion criteria (4 listed)
- age (<12 months, >16 years)
- weight (<12 kg, >50 kg)
- a known difficult airway
- risk of aspiration
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 |
|---|---|---|
| Ambu AuraOnceOropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O). | Device | Oropharyngeal leak pressure |
| Ambu AuraGainThe airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen) | Device | Fiberoptic position |
Primary outcome
oropharyngeal leak pressure
Time frame: 5 min
1 secondary outcome
fiberoptic position
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Derived from this study: PubMed 30315506Stogermuller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu(R) Aura Gain versus Ambu(R) Aura Once in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.
- Individual participant dataSharing planned: No
Related trials for Airway Management
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
Active, not recruiting
The Comfort of Proactive Sleep Apnea Therapy
Obstructive Sleep Apnea, Sleep Apnea
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu AuraOnce and Ambu AuraGain in people with Airway Management, run by Schulthess Klinik at 2 sites in 2 countries.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. 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?
Results are not available in the source record.
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: 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811042, which also lists 1 linked publication.
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 Jun 2016.