CricothyroidotomyNCT04005950
Comparison of a Conventional and a Realistic Self-modified Model
An observational study of Cricothyroidotomy and Difficult Airway, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended. Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cricothyroidotomy, Difficult Airway, Obesity
- What is being tested?
- Scalpel Bougie technique and modified Scalpel Bougie technique
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 21 Jul 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany
Who may be able to join
- written informed consent
- german language in speaking and writing
- capability of giving consent
Who cannot join
- participants unwilling or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model
According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.
Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.
Therefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.
As a control group the investigators used a conventional simple plastic model.
Read the detailed description
Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.
As a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.
35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.
For the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.
Primary endpoint is the evaluation of reality of the two different manikins.
- Conditions
- Cricothyroidotomy, Difficult Airway, Obesity
- Being tested
- Scalpel Bougie technique, modified Scalpel Bougie technique
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel Bougie techniqueDevice
ScalpelCric Set
modified Scalpel Bougie techniqueDevice
ScalpelCric Set plus speculum
| Study group | Role | What they receive |
|---|---|---|
| medical doctors | Not described Receives: Device: Scalpel Bougie technique; Device: modified Scalpel Bougie technique | |
| paramedics | Not described Receives: Device: Scalpel Bougie technique; Device: modified Scalpel Bougie technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of realistic applicability
using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)
Measured: 12 minutes
Secondary outcomes (1)
Time from initial handling equipment to a successful placement of the tracheal cannula
Measured: 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion21 Jul 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CricothyroidotomyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 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
- NCT04005950
- Sponsor's protocol ID
- ScalpelCric Advanced
- Status last verified
- Jul 2019
- First submitted
- 30 Jun 2019
- Last updated
- 23 Jul 2019
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model
- ClinicalTrials.gov ID
- NCT04005950
- Acronym / sponsor ID
- ScalpelCric Advanced
- Conditions
- Cricothyroidotomy, Difficult Airway, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 2 Jul 2019 (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.
According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.
Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.
Therefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.
As a control group the investigators used a conventional simple plastic model.
Detailed description
Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.
As a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.
35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.
For the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.
Primary endpoint is the evaluation of reality of the two different manikins.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical doctors | – | Device: Scalpel Bougie technique, Device: modified Scalpel Bougie technique |
| paramedics | – | Device: Scalpel Bougie technique, Device: modified Scalpel Bougie technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany
Key inclusion criteria (3 listed)
- written informed consent
- german language in speaking and writing
- capability of giving consent
Key exclusion criteria (1 listed)
- participants unwilling or unable to give informed 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 |
|---|---|---|
| Scalpel Bougie techniqueScalpelCric Set | Device | medical doctors, paramedics |
| modified Scalpel Bougie techniqueScalpelCric Set plus speculum | Device | medical doctors, paramedics |
Primary outcome
evaluation of realistic applicability
Time frame: 12 minutes
using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)
1 secondary outcome
Time from initial handling equipment to a successful placement of the tracheal cannula
Time frame: 300 seconds
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 23 Jul 2019.
Related trials for Cricothyroidotomy
Not yet recruiting
Mental Rehearsal in Emergency Cricothyroidotomy Training
Difficult Airway, Medical Training
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?
An observational study of Cricothyroidotomy and Difficult Airway, 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 1 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 23 Jul 2019. 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?
evaluation of realistic applicability (time frame: 12 minutes). 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 23 Jul 2019.