Learning ProblemTeachIntubNCT05145556
Teach Intubation by Novices in Anaesthesiology
A study testing Videolarygoscopy and conventional laryngoscopy in people with Learning Problem and Larynx, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Learning Problem, Larynx
- What is being tested?
- Videolarygoscopy and conventional laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2021to 1 Feb 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 Years
- capacity to consent
- Present written informed consent of the research participant
Who cannot join
- Age <18 years
- Lack of consent
- inability to consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
Marc Kriege, MD, 00496131170
About this study
Official title: Comparision of Direct Laryngoscopy and Video Laryngoscopy to Learn Successful Tracheal Intubation by Novices in Anaesthesiology
Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology
Read the detailed description
Video laryngoscopy has been recommended as an alternative during difficult conventional direct laryngoscopy using the Macintosh blade. However, successful visualisation of the larynx and tracheal intubation using some of the indirect laryngoscopes or video laryngoscopy requires hand-eye coordination. To best of our knowledge in the current literature there are no data how is the best educative way to learn successful tracheal intubation by novices in anaesthesiology.
- Conditions
- Learning Problem, Larynx
- Being tested
- Videolarygoscopy, conventional laryngoscopy
- Keywords
- Tracheal Intubation, Learning Technique, Laryngoscope
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolarygoscopyDevice
In a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea.
conventional laryngoscopyDevice
In a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy (McGrath Macintosh) | Experimental | First pass success rate using the videolaryngoscopy Receives: Device: Videolarygoscopy |
| conventional direct laryngoscopy | Experimental | First pass success rate using the conventional direct laryngoscopy Receives: Device: conventional laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success rate
successful tracheal intubation at the first attempt, compared to more than one attempt
Measured: at intubation in 60 seconds
Secondary outcomes (4)
Time to ventilation
From Insertion of the blase into the mouth until first ventilation
Measured: at intubation in 120 seconds
Cormack and Lehane Classification
after insert the device the user describe the glottis visualisation
Measured: at intubation in 120 seconds
Overall success rate
after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
Measured: at intubation in 120 seconds
Subjective Training Process
after 25 intubation attempts
Measured: at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start2 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning ProblemStudies 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
- Model description
- Starting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubations
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc MK Kriege, PD Dr, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145556
- Sponsor's protocol ID
- JohannesGUIT
- Acronym
- TeachIntub
- Status last verified
- Jan 2023
- First submitted
- 25 Nov 2021
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Direct Laryngoscopy and Video Laryngoscopy to Learn Successful Tracheal Intubation by Novices in Anaesthesiology
- ClinicalTrials.gov ID
- NCT05145556
- Acronym / sponsor ID
- TeachIntub / JohannesGUIT
- Conditions
- Learning Problem, Larynx
- Keywords
- Tracheal Intubation, Learning Technique, Laryngoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 Dec 2021 (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.
Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology
Detailed description
Video laryngoscopy has been recommended as an alternative during difficult conventional direct laryngoscopy using the Macintosh blade. However, successful visualisation of the larynx and tracheal intubation using some of the indirect laryngoscopes or video laryngoscopy requires hand-eye coordination. To best of our knowledge in the current literature there are no data how is the best educative way to learn successful tracheal intubation by novices in anaesthesiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Starting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubations
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy (McGrath Macintosh) | Experimental | Device: VideolarygoscopyFirst pass success rate using the videolaryngoscopy |
| conventional direct laryngoscopy | Experimental | Device: conventional laryngoscopyFirst pass success rate using the conventional direct laryngoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 Years
- capacity to consent
- Present written informed consent of the research participant
Key exclusion criteria (3 listed)
- Age <18 years
- Lack of consent
- inability to consent
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 |
|---|---|---|
| VideolarygoscopyIn a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea. | Device | Videolaryngoscopy (McGrath Macintosh) |
| conventional laryngoscopyIn a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea. | Device | conventional direct laryngoscopy |
Primary outcome
First pass success rate
Time frame: at intubation in 60 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
4 secondary outcomes
Time to ventilation
Time frame: at intubation in 120 seconds
Cormack and Lehane Classification
Time frame: at intubation in 120 seconds
Overall success rate
Time frame: at intubation in 120 seconds
Subjective Training Process
Time frame: at one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Marc MK Kriege, PD Dr principal investigator
University JG, Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolarygoscopy and conventional laryngoscopy in people with Learning Problem and Larynx, 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 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc MK Kriege, PD Dr (00496131170, MaKriege@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success rate (time frame: at intubation in 60 seconds). 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 25 Jan 2023.