Intubation; DifficultNCT01692522
Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children
A study testing Intubation in people with Intubation; Difficult, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Aug 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-16 years
- max 50kg
- ASA I-III
Who cannot join
- risk of aspiration
- known difficult airway
- congenital malformations respiratory tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children
The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.
Read the detailed description
After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation
- Conditions
- Intubation; Difficult
- Being tested
- Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
visualized blind intubation
| Study group | Role | What they receive |
|---|---|---|
| Ambu Aura-i | Experimental | intubation Receives: Procedure: Intubation |
| AirQ | Active comparator | intubation Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt visualized blind intubation success rate
Measured: how many seconds needed
Secondary outcomes (1)
Overall intubation success rate
Measured: how many seconds needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionAug 2014
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 Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz Theiler, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Greif, MD MME FERC, Study chair, University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692522
- Sponsor's protocol ID
- 093/12
- Status last verified
- Aug 2014
- First submitted
- 17 Sep 2012
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kleine-Brueggeney M, Nicolet A, Nabecker S, Seiler S, Stucki F, Greif R, Theiler L. Blind intubation of anaesthetised children with supraglottic airway devices AmbuAura-i and Air-Q cannot be recommended: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):631-9. doi: 10.1097/EJA.0000000000000261.
PubMed 26061874
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children
- ClinicalTrials.gov ID
- NCT01692522
- Acronym / sponsor ID
- 093/12
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Sep 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 investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.
Detailed description
After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu Aura-i | Experimental | Procedure: Intubationintubation |
| AirQ | Active comparator | Procedure: Intubationintubation |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 0-16 years
- max 50kg
- ASA I-III
Key exclusion criteria (3 listed)
- risk of aspiration
- known difficult airway
- congenital malformations respiratory tract
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 |
|---|---|---|
| Intubationvisualized blind intubation | Procedure or surgery | AirQ, Ambu Aura-i |
Primary outcome
First attempt visualized blind intubation success rate
Time frame: how many seconds needed
1 secondary outcome
Overall intubation success rate
Time frame: how many seconds needed
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 18 Aug 2014.
- Derived from this study: PubMed 26061874Kleine-Brueggeney M, Nicolet A, Nabecker S, Seiler S, Stucki F, Greif R, Theiler L. Blind intubation of anaesthetised children with supraglottic airway devices AmbuAura-i and Air-Q cannot be recommended: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):631-9. doi: 10.1097/EJA.0000000000000261.
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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.
Robert Greif, MD MME FERC study chair
University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Intubation; Difficult, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 3 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 18 Aug 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 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?
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?
First attempt visualized blind intubation success rate (time frame: how many seconds needed). 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 NCT01692522, 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 18 Aug 2014.