CricothyroidotomyNCT03741049
Evaluation of the ScalpelCric Set and Comparison With Two Further Techniques of Cricothyrotomy
An observational study of Cricothyroidotomy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cricothyroidotomy
- What is being tested?
- Scalpel Bougie technique (plastic laryngeal model), Seldinger technique (plastic laryngeal model) and Surgical technique (plastic laryngeal model)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2018to 20 Dec 2018
- 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 students (University Mainz), paramedics (DRK, MHD, ASB, ADAC), trainee anaesthetists and consultants (Department of anaesthesiology University hospital Mainz)
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 University Medicine Centre Mainz
Mainz, Rhineland Palatine, 55131
About this study
Official title: Evaluation of the Novel ScalpelCric Set for Cricothyrotomy Corresponding the Scalpel-Bougie Technique and Comparison With Two Further Techniques of Cricothyrotomy on a Plastic Laryngeal Model (A) and Comparison of the Novel ScalpelCric Set With Surgical Cricothyrotomy in a Porcine Laryngeal Model (B) Influence of Training (A+B) in a Simulation
During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique.
Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.
Read the detailed description
The investigators plan to recruit medical students (University Mainz), paramedics (employed in ambulance and rescue helicopter), trainee anaesthetists and consultants of the department of anesthesiology from the university hospital Mainz. After written informed consent the participants have to complete an pre-study questionnaire, than the participants get an information sheet about the 3 techniques and the investigators show the participants a short video demonstrating the different techniques. All participants have the opportunity to practice one insertion with each method on a plastic laryngeal model.
After that the participants have to perform each technique on the plastic model and the investigators measure the time from initially handling equipment to the final end-point, which the investigators take as a successful placement of the endotracheal tube verified by a fiberoptic position check.
- Conditions
- Cricothyroidotomy
- Being tested
- Scalpel Bougie technique (plastic laryngeal model), Seldinger technique (plastic laryngeal model), Surgical technique (plastic laryngeal model), Scalpel Bougie technique (porcine laryngeal model), Surgical technique (porcine laryngeal model)
- Keywords
- CVCI, Emergency medicine, Airway management, Cricothyroidotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel Bougie technique (plastic laryngeal model)Device
ScalpelBougie Set
Seldinger technique (plastic laryngeal model)Device
Melker Set
Surgical technique (plastic laryngeal model)Device
Scalpel and speculum
Scalpel Bougie technique (porcine laryngeal model)Device
ScalpelCric Set
Surgical technique (porcine laryngeal model)Device
Scalpel and speculum
| Study group | Role | What they receive |
|---|---|---|
| Consultants | Not described Receives: Device: Scalpel Bougie technique (plastic laryngeal model); Device: Seldinger technique (plastic laryngeal model); Device: Surgical technique (plastic laryngeal model); Device: Scalpel Bougie technique (porcine laryngeal model); Device: Surgical technique (porcine laryngeal model) | |
| Trainee anaesthetists | Not described Receives: Device: Scalpel Bougie technique (plastic laryngeal model); Device: Seldinger technique (plastic laryngeal model); Device: Surgical technique (plastic laryngeal model); Device: Scalpel Bougie technique (porcine laryngeal model); Device: Surgical technique (porcine laryngeal model) | |
| Paramedics | Not described Receives: Device: Scalpel Bougie technique (plastic laryngeal model); Device: Seldinger technique (plastic laryngeal model); Device: Surgical technique (plastic laryngeal model) | |
| Students | Not described Receives: Device: Scalpel Bougie technique (plastic laryngeal model); Device: Seldinger technique (plastic laryngeal model); Device: Surgical technique (plastic laryngeal model) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check
Measured: up to 3 minutes
Secondary outcomes (6)
Success rate in the first trial
Measured: up to 3 minutes
Number of trials
Measured: up to 3 minutes
Dimension of the tracheal trauma
horizontally and vertically in mm
Measured: up to 10 minutes
Comfort evaluation by the performer
Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult
Measured: up to 15 minutes
Influence of training on the time to decision making for cricothyrotomy
After performing the different techniques of cricothyrotomy on a platistic and a porcine laryngeal model, the participants will complete a simulator training for a cannot intubate and cannot ventilate scenario. Time to decide (measured in seconds) to perform cricothyrotomy will be measured from the beginning of the scenario.
Measured: up to 5 hours
Influence of training on choosing the technique
After performing the different techniques of cricothyrotomy on a platistic and a porcine laryngeal model, the participants will complete a simulator training for a cannot intubate and cannot ventilate scenario. The technique (Scalpel bougie, seldinger, surgical) of cricotyrotomy, chosen by the participant will be reported and compared with the preferred technique, the participant had chosen before performing the training.
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start13 Nov 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
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
- 200 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
- NCT03741049
- Sponsor's protocol ID
- 2018-13819
- Other IDs
- 2018
- Status last verified
- Feb 2019
- First submitted
- 8 Nov 2018
- Last updated
- 19 Feb 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 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Novel ScalpelCric Set for Cricothyrotomy Corresponding the Scalpel-Bougie Technique and Comparison With Two Further Techniques of Cricothyrotomy on a Plastic Laryngeal Model (A) and Comparison of the Novel ScalpelCric Set With Surgical Cricothyrotomy in a Porcine Laryngeal Model (B) Influence of Training (A+B) in a Simulation
- ClinicalTrials.gov ID
- NCT03741049
- Acronym / sponsor ID
- 2018-13819
- Conditions
- Cricothyroidotomy
- Keywords
- CVCI, Emergency medicine, Airway management, Cricothyroidotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 14 Nov 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.
During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique.
Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.
Detailed description
The investigators plan to recruit medical students (University Mainz), paramedics (employed in ambulance and rescue helicopter), trainee anaesthetists and consultants of the department of anesthesiology from the university hospital Mainz. After written informed consent the participants have to complete an pre-study questionnaire, than the participants get an information sheet about the 3 techniques and the investigators show the participants a short video demonstrating the different techniques. All participants have the opportunity to practice one insertion with each method on a plastic laryngeal model.
After that the participants have to perform each technique on the plastic model and the investigators measure the time from initially handling equipment to the final end-point, which the investigators take as a successful placement of the endotracheal tube verified by a fiberoptic position check.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consultants | – | Device: Scalpel Bougie technique (plastic laryngeal model), Device: Seldinger technique (plastic laryngeal model), Device: Surgical technique (plastic laryngeal model), Device: Scalpel Bougie technique (porcine laryngeal model), Device: Surgical technique (porcine laryngeal model) |
| Trainee anaesthetists | – | Device: Scalpel Bougie technique (plastic laryngeal model), Device: Seldinger technique (plastic laryngeal model), Device: Surgical technique (plastic laryngeal model), Device: Scalpel Bougie technique (porcine laryngeal model), Device: Surgical technique (porcine laryngeal model) |
| Paramedics | – | Device: Scalpel Bougie technique (plastic laryngeal model), Device: Seldinger technique (plastic laryngeal model), Device: Surgical technique (plastic laryngeal model) |
| Students | – | Device: Scalpel Bougie technique (plastic laryngeal model), Device: Seldinger technique (plastic laryngeal model), Device: Surgical technique (plastic laryngeal model) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical students (University Mainz), paramedics (DRK, MHD, ASB, ADAC), trainee anaesthetists and consultants (Department of anaesthesiology University hospital Mainz)
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 technique (plastic laryngeal model)ScalpelBougie Set | Device | Consultants, Paramedics, Students, Trainee anaesthetists |
| Seldinger technique (plastic laryngeal model)Melker Set | Device | Consultants, Paramedics, Students, Trainee anaesthetists |
| Surgical technique (plastic laryngeal model)Scalpel and speculum | Device | Consultants, Paramedics, Students, Trainee anaesthetists |
| Scalpel Bougie technique (porcine laryngeal model)ScalpelCric Set | Device | Consultants, Trainee anaesthetists |
| Surgical technique (porcine laryngeal model)Scalpel and speculum | Device | Consultants, Trainee anaesthetists |
Primary outcome
Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check
Time frame: up to 3 minutes
6 secondary outcomes
Success rate in the first trial
Time frame: up to 3 minutes
Number of trials
Time frame: up to 3 minutes
Dimension of the tracheal trauma
Time frame: up to 10 minutes
Comfort evaluation by the performer
Time frame: up to 15 minutes
Influence of training on the time to decision making for cricothyrotomy
Time frame: up to 5 hours
Influence of training on choosing the technique
Time frame: up to 5 hours
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 19 Feb 2019.
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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?
An observational study of Cricothyroidotomy, 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 19 Feb 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?
Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check (time frame: up to 3 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 19 Feb 2019.