Emergency Front of Neck Airway in ChildrenNCT04573790
A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children
An observational study of Emergency Front of Neck Airway in Children, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
A "cannot intubate, cannot oxygenate" (CICO) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. There is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergency Front of Neck Airway in Children
- What is being tested?
- eFONA
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jan 2019to 30 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich
Who may be able to join
- Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich
Who cannot join
- n.a.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Childrens Hospital, Department of Anaesthesia and Children's Research Centre
Zurich, 8032
About this study
A "cannot intubate, cannot oxygenate" (CICO) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. There is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. A modified emergency Front Of Neck Access (eFONA) technique using a rabbit cadaver model was developed to teach invasive airway protection in a CICO situation in children.
After watching an instructional video of our eFONA technique (tracheotomy, initial intubation with Frova catheter over which an endotracheal tube is inserted), 29 anaesthesiologists will perform two separate attempts on rabbit cadavers. The primary outcome is the success rate and the performance time overall and in subgroups of trained and untrained participants.
- Being tested
- eFONA
- Keywords
- Cannot intubate, cannot oxygenate in children, emergency front of neck airway, rabbit cadaver model, emergency tracheotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFONAProcedure or surgery
Surgical Tracheotomy
| Study group | Role | What they receive |
|---|---|---|
| Trained in eFONA | Trained participants completed our eFONA workshop within the last six month prior to participating in this study Receives: Procedure: eFONA | |
| Untrained in eFONA | Untrained participants had never taken part in our institutional eFONA workshop Receives: Procedure: eFONA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sucess rate
Correct positioning of the endotracheal tube in to the trachea
Measured: during study period, approx 15min
Performance time
Time needed to complete the surgical tracheotomy
Measured: during study period, max 240 sec
Secondary outcomes (1)
Secondary injuries
paratracheal placement of the ETT, perforation of the back wall or complete rupture of the trachea
Measured: during study period, approx 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start4 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Front of Neck Airway in ChildrenStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573790
- Sponsor's protocol ID
- eFONA KISPI
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 5 Oct 2020
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children
- ClinicalTrials.gov ID
- NCT04573790
- Acronym / sponsor ID
- eFONA KISPI
- Keywords
- Cannot intubate, cannot oxygenate in children, emergency front of neck airway, rabbit cadaver model, emergency tracheotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Oct 2020 (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.
A "cannot intubate, cannot oxygenate" (CICO) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. There is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. A modified emergency Front Of Neck Access (eFONA) technique using a rabbit cadaver model was developed to teach invasive airway protection in a CICO situation in children.
After watching an instructional video of our eFONA technique (tracheotomy, initial intubation with Frova catheter over which an endotracheal tube is inserted), 29 anaesthesiologists will perform two separate attempts on rabbit cadavers. The primary outcome is the success rate and the performance time overall and in subgroups of trained and untrained participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained in eFONA | – | Procedure: eFONATrained participants completed our eFONA workshop within the last six month prior to participating in this study |
| Untrained in eFONA | – | Procedure: eFONAUntrained participants had never taken part in our institutional eFONA workshop |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich
Key inclusion criteria (1 listed)
- Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich
Key exclusion criteria (1 listed)
- n.a.
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 |
|---|---|---|
| eFONASurgical Tracheotomy | Procedure or surgery | Trained in eFONA, Untrained in eFONA |
Primary outcome
Sucess rate
Time frame: during study period, approx 15min
Correct positioning of the endotracheal tube in to the trachea
Performance time
Time frame: during study period, max 240 sec
Time needed to complete the surgical tracheotomy
1 secondary outcome
Secondary injuries
Time frame: during study period, approx 15min
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 5 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Emergency Front of Neck Airway in Children
Enrolling by invitation
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Tracheostomy Complication, Emergency Front of Neck Airway in Children
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 Emergency Front of Neck Airway in Children, run by University Children's Hospital, Zurich 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 1 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 5 Oct 2020. 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?
Sucess rate (time frame: during study period, approx 15min). The study lists 2 primary outcomes in all. 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 5 Oct 2020.