Tracheostomy ComplicationeFONANCT07368179
Neck Rescue Access Comparison
A study testing Percutaneous Seldinger-Guided Tracheal Access (Melker) and scalpel-bougie tracheostomy in people with Tracheostomy Complication and Emergency Front of Neck Airway in Children, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Emergency front-of-neck access (eFONA) represents the final lifesaving intervention in a pediatric "can't intubate, can't oxygenate" scenario. Despite its importance, there is no consensus on the optimal eFONA technique in infants, and existing evidence is limited by low-fidelity models and a lack of randomized… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy Complication, Emergency Front of Neck Airway in Children, Anesthesia
- What is being tested?
- Percutaneous Seldinger-Guided Tracheal Access (Melker) and scalpel-bougie tracheostomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- board certified pediatric anesthesiologists or pediatric intensive care doctor
- informed consent signed
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Emergency Front-of-neck Access in Infants: A Crossover Trial Evaluating Surgical and Percutaneous eFONA Techniques in a Simulated Rabbit Model
Emergency front-of-neck access (eFONA) represents the final lifesaving intervention in a pediatric "can't intubate, can't oxygenate" scenario. Despite its importance, there is no consensus on the optimal eFONA technique in infants, and existing evidence is limited by low-fidelity models and a lack of randomized crossover comparisons. The objective of this randomized crossover simulation trial is to compare a surgical scalpel-bougie tracheostomy technique with a percutaneous Seldinger-guided technique under standardized, high-fidelity simulated infant emergency conditions. Using a rabbit cadaver model with simulated bleeding, physiological deterioration, and anatomical constraints, the study aims to assess time to successful ventilation and procedure-related injury patterns for both techniques.
Read the detailed description
With approval from the competent ethics committee, this single-center randomized crossover simulation trial will recruit board-certified pediatric anesthesiologists and pediatric intensivists. Participants will be randomized to perform either a percutaneous Seldinger-guided front-of-neck access technique or a surgical scalpel-bougie tracheostomy technique first, followed by crossover to the alternative technique.
Prior to assessment, participants will receive standardized video-based instruction for the assigned technique and will complete four supervised practice attempts on rabbit cadavers. A fifth attempt will be formally assessed. The same process will then be repeated after crossover to the second technique. Participants will be allowed to re-watch the instructional videos throughout the study.
All procedures will be performed on prepared rabbit cadavers in a high-fidelity simulated infant emergency environment. Anatomical realism will be enhanced using an infant mannequin head, shoulder roll, and standardized positioning. Psychological stress will be simulated using an audible oxygen saturation monitor with progressive desaturation and bradycardia. Physiological realism will be further enhanced by continuous simulated bleeding during the procedure using an infusion system delivering artificial blood near the trachea.
Performance time will be measured from skin contact to confirmed ventilation, defined by visible lung expansion. A procedure duration exceeding three minutes will be classified as failure. Procedure-related injuries, including damage to tracheal structures and posterior wall perforation, will be systematically documented. Each participant acts as their own control, minimizing inter-individual variability.
The study is designed to provide comparative data on performance efficiency and safety profiles of two fundamentally different pediatric eFONA techniques under realistic emergency conditions.
- Being tested
- Percutaneous Seldinger-Guided Tracheal Access (Melker), scalpel-bougie tracheostomy
- Keywords
- pediatric airway, tracheotomy, eFONA, CICO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Seldinger-Guided Tracheal Access (Melker)Procedure or surgery
Also called Melker
- The operator palpates and stabilizes the trachea in the midline. A syringe is attached to the introducer needle.
- The needle is advanced through the skin in the midline with continuous aspiration until intratracheal placement is confirmed by free air aspiration.
- A flexible guidewire is inserted through the needle into the tracheal lumen.
- The needle is removed while maintaining the guidewire in position.
- A dilator with integrated airway catheter is advanced over the guidewire using controlled rotational pressure.
- After intratracheal placement, the dilator and guidewire are removed.
- The cuffed airway catheter (inner diameter 3.5 mm) is connected to a ventilation device to establish ventilation.
scalpel-bougie tracheostomyProcedure or surgery
Also called SBT
- The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally 2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired. 3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly. 4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid 5. An 8 FR Frova catheter is inserted through the orifice into trachea. 6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Seldinger-Guided Tracheal Access (Melker) | Active comparator | Melker technique described in Interventions Receives: Procedure: Percutaneous Seldinger-Guided Tracheal Access (Melker) |
| scalpel-bougie tracheostomy (SBT) | Active comparator | SBT Technique described in Interventions Receives: Procedure: scalpel-bougie tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Time
Performance time between the percutaneous Seldinger-guided tracheal access and the scalpel-bougie tracheostomy technique. If tracheal access was not achieved within two minutes, the attempt was terminated and recorded as unsuccessful.
Measured: During the procedure; measured from initial palpation of the trachea until establishment of a secured airway with confirmed lung ventilation
Secondary outcomes (4)
Success rate of emergency front-of-neck airway establishment
Success was defined as establishment of a secured airway with confirmed lung ventilation using the assigned technique within two minutes. Confirmed lung ventilation was assessed by visible chest rise and ventilation of the lung.
Failure was defined as inability to establish a secured airway within two minutes, leading to termination of the attempt.
Measured: During the procedure
rate of thyroid cartilage injuries
Thyroid cartilage injury was assessed after each attempt by post-procedural inspection of the laryngeal framework. Injury was defined as any visible damage to the thyroid cartilage attributable to the procedure (e.g., fracture, laceration, perforation, or gross deformation). Injuries were recorded as present/absent; if present, the type of injury was documented.
Measured: Immediately after the procedure (post-procedural inspection)
rate of cricoid injuries
Cricoid injury was assessed after each attempt by post-procedural inspection of the laryngeal framework. Injury was defined as any visible damage to the cricoid cartilage attributable to the procedure (e.g., fracture, laceration, perforation, or gross deformation). Injuries were recorded as present or absent; if present, the type of injury was documented.
Measured: Immediately after the procedure (post-procedural inspection)
number of tracheal ring damaged
Tracheal ring damage was assessed after each attempt by post-procedural inspection of the trachea. Damage was defined as any visible injury to one or more tracheal rings attributable to the procedure (e.g., fracture, laceration, or perforation). Damage was recorded as present or absent; if present, the number of affected tracheal rings was documented.
Measured: Immediately after the procedure (post-procedural inspection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368179
- Sponsor's protocol ID
- FONA Riva2026
- Acronym
- eFONA
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Front-of-neck Access in Infants: A Crossover Trial Evaluating Surgical and Percutaneous eFONA Techniques in a Simulated Rabbit Model
- ClinicalTrials.gov ID
- NCT07368179
- Acronym / sponsor ID
- eFONA / FONA Riva2026
- Keywords
- pediatric airway, tracheotomy, eFONA, CICO
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
Emergency front-of-neck access (eFONA) represents the final lifesaving intervention in a pediatric "can't intubate, can't oxygenate" scenario. Despite its importance, there is no consensus on the optimal eFONA technique in infants, and existing evidence is limited by low-fidelity models and a lack of randomized crossover comparisons. The objective of this randomized crossover simulation trial is to compare a surgical scalpel-bougie tracheostomy technique with a percutaneous Seldinger-guided technique under standardized, high-fidelity simulated infant emergency conditions. Using a rabbit cadaver model with simulated bleeding, physiological deterioration, and anatomical constraints, the study aims to assess time to successful ventilation and procedure-related injury patterns for both techniques.
Detailed description
With approval from the competent ethics committee, this single-center randomized crossover simulation trial will recruit board-certified pediatric anesthesiologists and pediatric intensivists. Participants will be randomized to perform either a percutaneous Seldinger-guided front-of-neck access technique or a surgical scalpel-bougie tracheostomy technique first, followed by crossover to the alternative technique.
Prior to assessment, participants will receive standardized video-based instruction for the assigned technique and will complete four supervised practice attempts on rabbit cadavers. A fifth attempt will be formally assessed. The same process will then be repeated after crossover to the second technique. Participants will be allowed to re-watch the instructional videos throughout the study.
All procedures will be performed on prepared rabbit cadavers in a high-fidelity simulated infant emergency environment. Anatomical realism will be enhanced using an infant mannequin head, shoulder roll, and standardized positioning. Psychological stress will be simulated using an audible oxygen saturation monitor with progressive desaturation and bradycardia. Physiological realism will be further enhanced by continuous simulated bleeding during the procedure using an infusion system delivering artificial blood near the trachea.
Performance time will be measured from skin contact to confirmed ventilation, defined by visible lung expansion. A procedure duration exceeding three minutes will be classified as failure. Procedure-related injuries, including damage to tracheal structures and posterior wall perforation, will be systematically documented. Each participant acts as their own control, minimizing inter-individual variability.
The study is designed to provide comparative data on performance efficiency and safety profiles of two fundamentally different pediatric eFONA techniques under realistic emergency conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Seldinger-Guided Tracheal Access (Melker) | Active comparator | Procedure: Percutaneous Seldinger-Guided Tracheal Access (Melker)Melker technique described in Interventions |
| scalpel-bougie tracheostomy (SBT) | Active comparator | Procedure: scalpel-bougie tracheostomySBT Technique described in Interventions |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- board certified pediatric anesthesiologists or pediatric intensive care doctor
- informed consent signed
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 |
|---|---|---|
| Percutaneous Seldinger-Guided Tracheal Access (Melker)Also: Melker1. The operator palpates and stabilizes the trachea in the midline. A syringe is attached to the introducer needle. 2. The needle is advanced through the skin in the midline with continuous aspiration until intratracheal placement is confirmed by free air aspiration. 3. A flexible guidewire is inserted through the needle into the tracheal lumen. 4. The needle is removed while maintaining the guidewire in position. 5. A dilator with integrated airway catheter is advanced over the guidewire using controlled rotational pressure. 6. After intratracheal placement, the dilator and guidewire are removed. 7. The cuffed airway catheter (inner diameter 3.5 mm) is connected to a ventilation device to establish ventilation. | Procedure or surgery | Percutaneous Seldinger-Guided Tracheal Access (Melker) |
| scalpel-bougie tracheostomyAlso: SBT1. The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally 2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired. 3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly. 4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid 5. An 8 FR Frova catheter is inserted through the orifice into trachea. 6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently. | Procedure or surgery | scalpel-bougie tracheostomy (SBT) |
Primary outcome
Performance Time
Time frame: During the procedure; measured from initial palpation of the trachea until establishment of a secured airway with confirmed lung ventilation
Performance time between the percutaneous Seldinger-guided tracheal access and the scalpel-bougie tracheostomy technique. If tracheal access was not achieved within two minutes, the attempt was terminated and recorded as unsuccessful.
4 secondary outcomes
Success rate of emergency front-of-neck airway establishment
Time frame: During the procedure
rate of thyroid cartilage injuries
Time frame: Immediately after the procedure (post-procedural inspection)
rate of cricoid injuries
Time frame: Immediately after the procedure (post-procedural inspection)
number of tracheal ring damaged
Time frame: Immediately after the procedure (post-procedural inspection)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Seldinger-Guided Tracheal Access (Melker) and scalpel-bougie tracheostomy in people with Tracheostomy Complication and Emergency Front of Neck Airway in Children, 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 2 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: enrolling by invitation, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: During the procedure; measured from initial palpation of the trachea until establishment of a secured airway with confirmed lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.