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Emergency Front of the NecK Access (eFONA) in Children (eFONA)

Primary Purpose

Pediatric Anesthesia, Intubation;Difficult

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
a rapid sequence tracheostomy (RST) on rabbit cadaver
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Anesthesia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria are informed consent, no previous experience in FONA.

Exclusion Criteria:

none

Sites / Locations

  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pediatric anesthesiologist

Pediatric intensivists

Pediatric surgeons

Pediatric emergency physicians

Arm Description

10 rapid sequence tracheostomy (RST) on rabbit cadaver

10 rapid sequence tracheostomy (RST) on rabbit cadaver

10 rapid sequence tracheostomy (RST) on rabbit cadaver

10 rapid sequence tracheostomy (RST) on rabbit cadaver

Outcomes

Primary Outcome Measures

Performance time
The primary outcome will be performance time of RST representing the time from touching the skin until ventilation of the trachea (visualized by lung expansion) indicating the artificial airway as established. Performance time will yield learning curves. The declared intention is to perform RST in less than 60 seconds. Failed/aborted RST will be registered as a 5-minute attempt

Secondary Outcome Measures

Number of attempts
Number of attempts to perform the skill in <60 s
Number of attempts for plateau
Number of attempts to reach a time plateau
Preparation of the trachea
Time to vertical incision of the trachea with the sharp tip scissors
Vertical incision
Time to vertical incision of the trachea with the sharp tip scissors
Training
Number of times that training video was watched
Suitability
The subjective rating of the suitability of the given training model

Full Information

First Posted
June 18, 2018
Last Updated
January 10, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03576352
Brief Title
Emergency Front of the NecK Access (eFONA) in Children
Acronym
eFONA
Official Title
Pediatric Emergency Front of the Neck Access (eFONA): Assessing a Novel Experiential Learning Approach
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
December 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study participants will be shown an illustrated training video demonstrating and explaining the RST. The video may be reviewed until the participant feels confident to perform procedure. The Rapid Sequence Tracheostomy (RST) consists of the following steps: Orientational palpation and vertical midline skin incision followed by separation of the strap muscles Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp Perform a vertical puncture with a tip scissors between the Cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length. An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated. Teaching methodology: Prior to the hands-on training of eFONA, all participants shall watch a 2-minute training video of RST performed on rabbit cadaver following the steps outlined above. During video demonstration, no additional explanation or support will be provided. Once study participants express confidence to perform the skill, participants shall attempt to perform the RST 10 times. During the RST procedure no additional explanation or support will be provided. Study participants will be allowed to watch the video again between attempts, if needed. Each attempt will be video recorded and time recorded for rater analysis, as outlined above. Successful tracheotomy is defined as ventilation of the lungs by way of a standard self-inflating bag that is to be connected to the tracheal tube or visual confirmation of the tube being placed at least 2 cm inside the trachea (dissection of the rabbit cadaver performed by assistant).
Detailed Description
Current difficult airway algorithms end with the need for tracheal airway access to be obtained via Front Of Neck Access (FONA) to achieve oxygenation. In children < 8 years existing recommendations and the literature do not offer guidance on how to perform emergent FONA. Emergent tracheotomy is the potentially life-saving procedure - which needs to be performed without delay. When emergent tracheotomy is attempted in children < 8 years of age, there is a substantial risk for complications. As a result, health care providers who do not have routine at performing this procedure are often reluctant to perform FONA, Diameters, vertical/horizontal dimensions, vocal cord distance, larynx position, and cricothyroid membrane size of the rabbit airway suggest considerable similarities with infant airways, making it a good model to learn this technique. The FONA rapid sequence technique (RST) is a simple technique suitable for emergent pediatric tracheotomy. RST outlines 4 clearly defined steps, that enable airway establishment. Step 1: Vertical midline skin incision and separate the strap muscles Step 2: Expose trachea and cricoid through palpation, lift and immobilize trachea with a clamp Step 3: Vertical trachea incision with the sharp tip scissors (2 cm) Step 4: Open the trachea and insert the tube The steps are easy to perform, if sufficiently practiced. Anesthesiologist, pediatric intensivists, surgeons, and emergency physicians who are most likely to need to perform FONA in small children, shall learn to perform RST emergent pediatric tracheotomy in less than 60 seconds. The investigators seek to measure and study learning curves of participants for establishing an artificial airway using the RST. Hypothesis: After having practiced the procedure 10 times, 80% of study participants will not be able to successfully demonstrate FONA within 60 seconds. Alternative hypothesis: study participants will be able to successfully demonstrate FONA within 60 seconds. Single-center interventional trial. The only inclusion criterion is informed consent. A high quality instructional video demonstrating the RST on a rabbit cadaver will teach the participants. Performance time will be defined (from touching the skin until ventilation of the trachea with a standard self-inflating bag connected to the tube). The investigators seek to assess the learning curves of participants. Sample size. In order to obtain a lower limit of the 95% Confidence interval of 80% success in FONA the investigators would need 40 study participants assuming 2 failures by the 10th attempt. Statistical methods: Descriptive statistics for demographics. To establish the learning curve the increase over the 3 attempts will be analyzed by repeated ANOVA or Friedman. For the reasons outlined above the investigators will provide a suitable and valid training model for pediatric airway practitioners to practice the invasive front of neck access technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Anesthesia, Intubation;Difficult

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Anesthesiologist, pediatric intensivists, surgeons, and emergency physicians who are most likely to need to perform FONA in small children, shall learn to perform RST emergent pediatric tracheotomy in less than 60 seconds. The investigators seek to measure and study their learning curves for establishing an artificial airway using the RST. Single-center interventional trial. The only inclusion criterion is informed consent. A high quality instructional video demonstrating the RST on a rabbit cadaver will teach the participants. Performance time will be defined (from touching the skin until ventilation of the trachea with a standard self-inflating bag connected to the tube).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric anesthesiologist
Arm Type
Experimental
Arm Description
10 rapid sequence tracheostomy (RST) on rabbit cadaver
Arm Title
Pediatric intensivists
Arm Type
Experimental
Arm Description
10 rapid sequence tracheostomy (RST) on rabbit cadaver
Arm Title
Pediatric surgeons
Arm Type
Experimental
Arm Description
10 rapid sequence tracheostomy (RST) on rabbit cadaver
Arm Title
Pediatric emergency physicians
Arm Type
Experimental
Arm Description
10 rapid sequence tracheostomy (RST) on rabbit cadaver
Intervention Type
Other
Intervention Name(s)
a rapid sequence tracheostomy (RST) on rabbit cadaver
Intervention Description
The Rapid Sequence Tracheostomy (RST) consists of the following steps: Orientational palpation and vertical midline skin incision followed by separation of the strap muscles Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp Perform a vertical puncture with a tip scissors between the Cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length. An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated.
Primary Outcome Measure Information:
Title
Performance time
Description
The primary outcome will be performance time of RST representing the time from touching the skin until ventilation of the trachea (visualized by lung expansion) indicating the artificial airway as established. Performance time will yield learning curves. The declared intention is to perform RST in less than 60 seconds. Failed/aborted RST will be registered as a 5-minute attempt
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Number of attempts
Description
Number of attempts to perform the skill in <60 s
Time Frame
1 hour
Title
Number of attempts for plateau
Description
Number of attempts to reach a time plateau
Time Frame
1 hour
Title
Preparation of the trachea
Description
Time to vertical incision of the trachea with the sharp tip scissors
Time Frame
60 seconds
Title
Vertical incision
Description
Time to vertical incision of the trachea with the sharp tip scissors
Time Frame
60 seconds
Title
Training
Description
Number of times that training video was watched
Time Frame
1 hour
Title
Suitability
Description
The subjective rating of the suitability of the given training model
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria are informed consent, no previous experience in FONA. Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greif Robert, Prof.
Organizational Affiliation
Department Anesthesia and Pain Therapy, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31812268
Citation
Ulmer F, Lennertz J, Greif R, Butikofer L, Theiler L, Riva T. Emergency front of neck access in children: a new learning approach in a rabbit model. Br J Anaesth. 2020 Jul;125(1):e61-e68. doi: 10.1016/j.bja.2019.11.002. Epub 2019 Dec 4.
Results Reference
derived

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Emergency Front of the NecK Access (eFONA) in Children

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