Pediatric AnesthesiaeFONANCT03576352
Emergency Front of the NecK Access (eFONA) in Children
A study testing a rapid sequence tracheostomy (RST) on rabbit cadaver in people with Pediatric Anesthesia and Intubation;Difficult, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Anesthesia, Intubation;Difficult
- What is being tested?
- a rapid sequence tracheostomy (RST) on rabbit cadaver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2018to 23 Dec 2018
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria are informed consent, no previous experience in FONA.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Emergency Front of the Neck Access (eFONA): Assessing a Novel Experiential Learning Approach
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:
Read more
- 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).
Read the 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.
- Conditions
- Pediatric Anesthesia, Intubation;Difficult
- Being tested
- a rapid sequence tracheostomy (RST) on rabbit cadaver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a rapid sequence tracheostomy (RST) on rabbit cadaverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric anesthesiologist | Experimental | 10 rapid sequence tracheostomy (RST) on rabbit cadaver Receives: Other: a rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric intensivists | Experimental | 10 rapid sequence tracheostomy (RST) on rabbit cadaver Receives: Other: a rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric surgeons | Experimental | 10 rapid sequence tracheostomy (RST) on rabbit cadaver Receives: Other: a rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric emergency physicians | Experimental | 10 rapid sequence tracheostomy (RST) on rabbit cadaver Receives: Other: a rapid sequence tracheostomy (RST) on rabbit cadaver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 seconds
Secondary outcomes (6)
Number of attempts
Number of attempts to perform the skill in <60 s
Measured: 1 hour
Number of attempts for plateau
Number of attempts to reach a time plateau
Measured: 1 hour
Preparation of the trachea
Time to vertical incision of the trachea with the sharp tip scissors
Measured: 60 seconds
Vertical incision
Time to vertical incision of the trachea with the sharp tip scissors
Measured: 60 seconds
Training
Number of times that training video was watched
Measured: 1 hour
Suitability
The subjective rating of the suitability of the given training model
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 May 2018
- Primary completion10 Nov 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greif Robert, Prof., Study chair, Department Anesthesia and Pain Therapy, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576352
- Sponsor's protocol ID
- Riva-Ulmer2017
- Acronym
- eFONA
- Status last verified
- Jan 2019
- First submitted
- 18 Jun 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31812268
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Emergency Front of the Neck Access (eFONA): Assessing a Novel Experiential Learning Approach
- ClinicalTrials.gov ID
- NCT03576352
- Acronym / sponsor ID
- eFONA / Riva-Ulmer2017
- Conditions
- Pediatric Anesthesia, Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 3 Jul 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pediatric anesthesiologist | Experimental | Other: a rapid sequence tracheostomy (RST) on rabbit cadaver10 rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric intensivists | Experimental | Other: a rapid sequence tracheostomy (RST) on rabbit cadaver10 rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric surgeons | Experimental | Other: a rapid sequence tracheostomy (RST) on rabbit cadaver10 rapid sequence tracheostomy (RST) on rabbit cadaver |
| Pediatric emergency physicians | Experimental | Other: a rapid sequence tracheostomy (RST) on rabbit cadaver10 rapid sequence tracheostomy (RST) on rabbit cadaver |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria are informed consent, no previous experience in FONA.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| a rapid sequence tracheostomy (RST) on rabbit cadaverThe Rapid Sequence Tracheostomy (RST) consists of the following steps: 1. Orientational palpation and vertical midline skin incision followed by separation of the strap muscles 2. Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp 3. 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. 4. An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated. | Other | Pediatric anesthesiologist, Pediatric emergency physicians, Pediatric intensivists, Pediatric surgeons |
Primary outcome
Performance time
Time frame: 60 seconds
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
6 secondary outcomes
Number of attempts
Time frame: 1 hour
Number of attempts for plateau
Time frame: 1 hour
Preparation of the trachea
Time frame: 60 seconds
Vertical incision
Time frame: 60 seconds
Training
Time frame: 1 hour
Suitability
Time frame: 1 hour
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 11 Jan 2019.
- Derived from this study: PubMed 31812268Ulmer 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.
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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.
Greif Robert, Prof. study chair
Department Anesthesia and Pain Therapy, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a rapid sequence tracheostomy (RST) on rabbit cadaver in people with Pediatric Anesthesia and Intubation;Difficult, run by Insel Gruppe AG, University Hospital Bern 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 11 Jan 2019. 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?
Performance time (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576352, which also lists 1 linked publication.
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 11 Jan 2019.