- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573790
A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8032
- University Childrens Hospital, Department of Anaesthesia and Children's Research Centre
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich
Exclusion Criteria:
- n.a.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trained in eFONA
Trained participants completed our eFONA workshop within the last six month prior to participating in this study
|
Surgical Tracheotomy
|
Untrained in eFONA
Untrained participants had never taken part in our institutional eFONA workshop
|
Surgical Tracheotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sucess rate
Time Frame: during study period, approx 15min
|
Correct positioning of the endotracheal tube in to the trachea
|
during study period, approx 15min
|
Performance time
Time Frame: during study period, max 240 sec
|
Time needed to complete the surgical tracheotomy
|
during study period, max 240 sec
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary injuries
Time Frame: during study period, approx 15min
|
paratracheal placement of the ETT, perforation of the back wall or complete rupture of the trachea
|
during study period, approx 15min
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- eFONA KISPI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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