Airway ManagementLearnaBladeNCT03571295
Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management
A study testing King Vision aBlade and direct laryngoscopy in people with Airway Management and Videolaryngoscopy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Airway Management, Videolaryngoscopy
- What is being tested?
- King Vision aBlade and direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 1 Sep 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1 to 2
- written informed consent from both legal guardians
- children who were scheduled for nonemergency surgery with requirement of endotracheal intubation
Who cannot join
- known or predicted difficult airway
- increased risk for pulmonary aspiration
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists
The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.
Read the detailed description
After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.
- Conditions
- Airway Management, Videolaryngoscopy
- Being tested
- King Vision aBlade, direct laryngoscopy
- Keywords
- pediatric airway management, learning curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision aBladeDevice
endotracheal intubation performed with King Vision aBlade
direct laryngoscopyDevice
endotracheal intubation performed with direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscopy | Experimental | Not described Receives: Device: King Vision aBlade |
| direct laryngoscopy | Experimental | Not described Receives: Device: direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt success rate of endotracheal intubation
yes/no
Measured: operation day
Secondary outcomes (1)
total time for successful intubation
in sec
Measured: operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571295
- Sponsor's protocol ID
- Learn a Blade 1.0
- Acronym
- LearnaBlade
- Status last verified
- Aug 2021
- First submitted
- 22 May 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists
- ClinicalTrials.gov ID
- NCT03571295
- Acronym / sponsor ID
- LearnaBlade / Learn a Blade 1.0
- Conditions
- Airway Management, Videolaryngoscopy
- Keywords
- pediatric airway management, learning curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Jun 2018 (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 investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.
Detailed description
After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscopy | Experimental | Device: King Vision aBlade |
| direct laryngoscopy | Experimental | Device: direct laryngoscopy |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA 1 to 2
- written informed consent from both legal guardians
- children who were scheduled for nonemergency surgery with requirement of endotracheal intubation
Key exclusion criteria (2 listed)
- known or predicted difficult airway
- increased risk for pulmonary 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 |
|---|---|---|
| King Vision aBladeendotracheal intubation performed with King Vision aBlade | Device | videolaryngoscopy |
| direct laryngoscopyendotracheal intubation performed with direct laryngoscopy | Device | direct laryngoscopy |
Primary outcome
first attempt success rate of endotracheal intubation
Time frame: operation day
yes/no
1 secondary outcome
total time for successful intubation
Time frame: operation day
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 30 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Vision aBlade and direct laryngoscopy in people with Airway Management and Videolaryngoscopy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 2 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 30 Aug 2021. 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 Germany. 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 success rate of endotracheal intubation (time frame: operation day). 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 30 Aug 2021.