Tracheostomy ComplicationNCT05499273
Pediatric Neck Rescue Access Comparison
A study testing scalpel-bougie tracheostomy and rapid sequence tracheotomy in people with Tracheostomy Complication and Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. 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, Anesthesia
- What is being tested?
- scalpel-bougie tracheostomy and rapid sequence tracheotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 May 2022to 8 Mar 2023
- 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
- 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.
About this study
Official title: Pediatric Neck Rescue: Randomized Comparison of Two Emergency Approaches to the Trachea in an Advanced Simulated Rabbit Model
Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.
Read the detailed description
With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.
- Conditions
- Tracheostomy Complication, Anesthesia
- Being tested
- scalpel-bougie tracheostomy, rapid sequence tracheotomy
- 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.
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
- 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.
- Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly.
- Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid
- An 8 FR Frova catheter is inserted through the orifice into trachea.
- A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.
rapid sequence tracheotomyProcedure or surgery
Also called RST
- 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.
- A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.
| Study group | Role | What they receive |
|---|---|---|
| scalpel-bougie tracheostomy (SBT) | Active comparator | SBT technique described in Interventions Receives: Procedure: scalpel-bougie tracheostomy; Procedure: rapid sequence tracheotomy |
| rapid sequence tracheotomy (RST | Active comparator | RST technique described in Interventions Receives: Procedure: scalpel-bougie tracheostomy; Procedure: rapid sequence tracheotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Time
performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.
Measured: 2 min
Secondary outcomes (4)
rate of cricoid injuries
rate of cricoid cartilage injuries during procedure, that would preclude ventilation measured in %
Measured: 2 min
Succes rate
succes rate in %
Measured: 2 min
rate of thyroid injuries
rate of thyroid cartilage injuries during the procedure that would preclude ventilation, measured in %
Measured: 2 min
number of tracheal ring damaged
number of damaged tracheal rings and perforation of the posterior tracheal wall during procedure
Measured: 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start25 May 2022
- Primary completion3 Mar 2023
- Study completion8 Mar 2023
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 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 (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Responsible party
- Principal investigator, Thomas Riva, Insel Gruppe AG, University Hospital Bern
- Investigators
- Thomas Riva, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499273
- Sponsor's protocol ID
- Riva-Ulmer2022
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riva T, Goerge S, Fuchs A, Greif R, Huber M, Lusardi AC, Riedel T, Ulmer FF, Disma N. Emergency front-of-neck access in infants: A pragmatic crossover randomized control trial comparing two approaches on a simulated rabbit model. Paediatr Anaesth. 2024 Mar;34(3):225-234. doi: 10.1111/pan.14796. Epub 2023 Nov 10.
PubMed 37950428
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Neck Rescue: Randomized Comparison of Two Emergency Approaches to the Trachea in an Advanced Simulated Rabbit Model
- ClinicalTrials.gov ID
- NCT05499273
- Acronym / sponsor ID
- Riva-Ulmer2022
- Conditions
- Tracheostomy Complication, Anesthesia
- Keywords
- pediatric airway, tracheotomy, eFONA, CICO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Study start
- 25 May 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 12 Aug 2022 (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.
Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.
Detailed description
With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scalpel-bougie tracheostomy (SBT) | Active comparator | Procedure: scalpel-bougie tracheostomy, Procedure: rapid sequence tracheotomySBT technique described in Interventions |
| rapid sequence tracheotomy (RST | Active comparator | Procedure: scalpel-bougie tracheostomy, Procedure: rapid sequence tracheotomyRST 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 |
|---|---|---|
| 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 | rapid sequence tracheotomy (RST, scalpel-bougie tracheostomy (SBT) |
| rapid sequence tracheotomyAlso: RST1. 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. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently. | Procedure or surgery | rapid sequence tracheotomy (RST, scalpel-bougie tracheostomy (SBT) |
Primary outcome
Performance Time
Time frame: 2 min
performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.
4 secondary outcomes
rate of cricoid injuries
Time frame: 2 min
Succes rate
Time frame: 2 min
rate of thyroid injuries
Time frame: 2 min
number of tracheal ring damaged
Time frame: 2 min
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 9 Mar 2023.
- Derived from this study: PubMed 37950428Riva T, Goerge S, Fuchs A, Greif R, Huber M, Lusardi AC, Riedel T, Ulmer FF, Disma N. Emergency front-of-neck access in infants: A pragmatic crossover randomized control trial comparing two approaches on a simulated rabbit model. Paediatr Anaesth. 2024 Mar;34(3):225-234. doi: 10.1111/pan.14796. Epub 2023 Nov 10.
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Enrolling by invitation
Neck Rescue Access Comparison
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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.
Thomas Riva, MD principal investigator
University of 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 scalpel-bougie tracheostomy and rapid sequence tracheotomy in people with Tracheostomy Complication and Anesthesia, 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: finished, as of the sponsor's last update on 9 Mar 2023. 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: 2 min). 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 NCT05499273, 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 9 Mar 2023.