ApneaNCT01718782
Laryngeal Mask Ambu Aura Once vs. Supreme in Children
A study testing laryngeal mask Ambu AuraOnce and laryngeal mask LMA Supreme in people with Apnea, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea
- What is being tested?
- laryngeal mask Ambu AuraOnce and laryngeal mask LMA Supreme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2013to May 2014
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 1-10 years
- ASA I - III
- Elective procedure in general anaesthesia
- Parental informed consent
Who cannot join
- Non fasting patient
- Body mass index > 35 kg/m2
- Cervical spine pathologies or peripheral neurologic deficiences
- Malformations of upper airway or head
- Anamnestic hiatus hernia or esophageal reflux
- Status post operation of stomach or esophagus
- Recurrent respiratory infection or obstructive airway disease
- Non elective procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children
The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.
Read the detailed description
Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.
- Conditions
- Apnea
- Being tested
- laryngeal mask Ambu AuraOnce, laryngeal mask LMA Supreme
- Keywords
- laryngeal mask, leakage pressure, ventilation
- Medical subject headings
- Apnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal mask Ambu AuraOnceDevice
airway management and mechanical ventilation with laryngeal mask
laryngeal mask LMA SupremeDevice
airway management and mechanical ventilation with laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| laryngeal mask Ambu AuraOnce | Active comparator | laryngeal mask Ambu AuraOnce Receives: Device: laryngeal mask Ambu AuraOnce |
| laryngeal mask LMA Supreme | Active comparator | laryngeal mask LMA Supreme Receives: Device: laryngeal mask LMA Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage pressure [cmH2O]
After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation
Measured: 1min
Secondary outcomes (3)
Efficient ventilation [mL],
After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation
Measured: 3min
tidal volume [mL],
Measured: 3 minutes
stomach insufflation [yes or no]
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Other studies with the same protocol have already published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Paal, Medical University Innsbruck
- Investigators
- Peter Paal, MD,DESA,EDIC, Principal investigator, University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718782
- Sponsor's protocol ID
- AN4111 292/4.23
- Status last verified
- May 2014
- First submitted
- 27 Sep 2012
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children
- ClinicalTrials.gov ID
- NCT01718782
- Acronym / sponsor ID
- AN4111 292/4.23
- Conditions
- Apnea
- Keywords
- laryngeal mask, leakage pressure, ventilation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other studies with the same protocol have already published.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Oct 2012 (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 purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.
Detailed description
Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laryngeal mask Ambu AuraOnce | Active comparator | Device: laryngeal mask Ambu AuraOncelaryngeal mask Ambu AuraOnce |
| laryngeal mask LMA Supreme | Active comparator | Device: laryngeal mask LMA Supremelaryngeal mask LMA Supreme |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1-10 years
- ASA I - III
- Elective procedure in general anaesthesia
- Parental informed consent
Key exclusion criteria (8 listed)
- Non fasting patient
- Body mass index > 35 kg/m2
- Cervical spine pathologies or peripheral neurologic deficiences
- Malformations of upper airway or head
- Anamnestic hiatus hernia or esophageal reflux
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 |
|---|---|---|
| laryngeal mask Ambu AuraOnceairway management and mechanical ventilation with laryngeal mask | Device | laryngeal mask Ambu AuraOnce |
| laryngeal mask LMA Supremeairway management and mechanical ventilation with laryngeal mask | Device | laryngeal mask LMA Supreme |
Primary outcome
Leakage pressure [cmH2O]
Time frame: 1min
After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation
3 secondary outcomes
Efficient ventilation [mL],
Time frame: 3min
tidal volume [mL],
Time frame: 3 minutes
stomach insufflation [yes or no]
Time frame: 3 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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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.
Peter Paal, MD,DESA,EDIC principal investigator
University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal mask Ambu AuraOnce and laryngeal mask LMA Supreme in people with Apnea, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 15 May 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Leakage pressure [cmH2O] (time frame: 1min). 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 15 May 2014.