NCT04573790

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 28, 2020

Last Update Submit

September 28, 2020

Conditions

Keywords

Cannot intubate, cannot oxygenate in childrenemergency front of neck airwayrabbit cadaver modelemergency tracheotomy

Outcome Measures

Primary Outcomes (2)

  • Sucess rate

    Correct positioning of the endotracheal tube in to the trachea

    during study period, approx 15min

  • Performance time

    Time needed to complete the surgical tracheotomy

    during study period, max 240 sec

Secondary Outcomes (1)

  • Secondary injuries

    during study period, approx 15min

Study Arms (2)

Trained in eFONA

Trained participants completed our eFONA workshop within the last six month prior to participating in this study

Procedure: eFONA

Untrained in eFONA

Untrained participants had never taken part in our institutional eFONA workshop

Procedure: eFONA

Interventions

eFONAPROCEDURE

Surgical Tracheotomy

Trained in eFONAUntrained in eFONA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • n.a.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Childrens Hospital, Department of Anaesthesia and Children's Research Centre

Zurich, 8032, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

January 4, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations