A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children

Emergency Front of Neck Airway in Children Clinical Trial

Official title:

A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573790
• Other study ID #: eFONA KISPI
• Status: Completed
• Start date: January 4, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich

Exclusion Criteria:

• n.a.

Related Conditions & MeSH terms

• Emergencies
• Emergency Front of Neck Airway in Children

Intervention

Procedure:
• eFONA
Surgical Tracheotomy

Locations

Country	Name	City	State
Switzerland	University Childrens Hospital, Department of Anaesthesia and Children's Research Centre	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sucess rate	Correct positioning of the endotracheal tube in to the trachea	during study period, approx 15min
Primary	Performance time	Time needed to complete the surgical tracheotomy	during study period, max 240 sec
Secondary	Secondary injuries	paratracheal placement of the ETT, perforation of the back wall or complete rupture of the trachea	during study period, approx 15min