Airway ObstructionNCT03238950
Cricothyroidotomy Training for Physicians Outcomes Study
A study testing Porcine model and Synthetic model in people with Airway Obstruction, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will assess whether the type of simulation model used in cricothyroidotomy training has an effect on the subsequent confidence and competence in the procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Porcine model and Synthetic model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 1 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medically trained healthcare professionals working in Anaesthetics, Emergency Medicine or General Surgery as these doctors may be expected to complete a surgical cricothyroidotomy despite infrequently performing the procedure.
- The healthcare professionals can be from Foundation Year 1 to before Certificates of Completion of Training (CCT). Those who are out of training and are not yet at consultant level are also eligible.
- Able to provide informed consent.
Who cannot join
- Healthcare professionals who already complete surgical airways on a regular basis (e.g. Ear Nose Throat or Maxillofacial trainees) as these doctors may already be competent prior to training.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?
This study will assess whether the type of simulation model used in cricothyroidotomy training has an effect on the subsequent confidence and competence in the procedure.
Read the detailed description
This is a Pilot study - prospective randomised controlled trial involving:
- Assessment of ability to complete a surgical cricothyroidotomy
- Completion of questionnaire prior to training and prior to assessment
Prior to beginning training, questionnaires will be completed by all participants asking their level of previous training. Current confidence level for completion of cricothyroidotomy will be marked on a visual analogue scale (VAS).
Training will then be completed with each group using the appropriate manikin type - porcine or synthetic. This will consist of didactic information on the procedure delivered via recorded information to standardise this initial training, and then proceeding to supervised practice of the procedure for two occasions. This will be completed by the same trainer, with the same information given to both groups. Questions to clarify how to perform the procedure will be permitted.
The second questionnaire will be given to the trainees on completion of training to mark on a visual analogue scale their confidence level at this point.
Assessment will then be completed later the day comprising of assessment of completion of surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be different to the porcine manikin used for training. The assessment will time the trainees from start to completion of airway insertion, as well as a checklist of activities to be achieved. The porcine manikins will then be dissected to identify if correct location for insertion was achieved and complications. The same amount of time will be given between groups training and assessment.
- Conditions
- Airway Obstruction
- Being tested
- Porcine model, Synthetic model
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine modelOther
participants to conduct training on porcine model
Synthetic modelOther
participants to conduct training on synthetic model
| Study group | Role | What they receive |
|---|---|---|
| Porcine Group | Other | Training conducted on Porcine model Receives: Other: Porcine model |
| Synthetic | Other | Training conducted on synthetic model Receives: Other: Synthetic model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
time
Measured: 1 day
Secondary outcomes (2)
Success rate for cricothyroidotomy
subjective reporting of confidence through questionnaire
Measured: 1 day
Complication rate for cricothyroidotomy
subjective reporting of confidence through questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jul 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Why it stopped: This study has never actually started as waiting on funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Helme, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238950
- Sponsor's protocol ID
- 2017SUR96
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?
- ClinicalTrials.gov ID
- NCT03238950
- Acronym / sponsor ID
- 2017SUR96
- Conditions
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has never actually started as waiting on funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 3 Aug 2017 (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.
This study will assess whether the type of simulation model used in cricothyroidotomy training has an effect on the subsequent confidence and competence in the procedure.
Detailed description
This is a Pilot study - prospective randomised controlled trial involving:
- Assessment of ability to complete a surgical cricothyroidotomy
- Completion of questionnaire prior to training and prior to assessment
Prior to beginning training, questionnaires will be completed by all participants asking their level of previous training. Current confidence level for completion of cricothyroidotomy will be marked on a visual analogue scale (VAS).
Training will then be completed with each group using the appropriate manikin type - porcine or synthetic. This will consist of didactic information on the procedure delivered via recorded information to standardise this initial training, and then proceeding to supervised practice of the procedure for two occasions. This will be completed by the same trainer, with the same information given to both groups. Questions to clarify how to perform the procedure will be permitted.
The second questionnaire will be given to the trainees on completion of training to mark on a visual analogue scale their confidence level at this point.
Assessment will then be completed later the day comprising of assessment of completion of surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be different to the porcine manikin used for training. The assessment will time the trainees from start to completion of airway insertion, as well as a checklist of activities to be achieved. The porcine manikins will then be dissected to identify if correct location for insertion was achieved and complications. The same amount of time will be given between groups training and assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porcine Group | Other | Other: Porcine modelTraining conducted on Porcine model |
| Synthetic | Other | Other: Synthetic modelTraining conducted on synthetic model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Medically trained healthcare professionals working in Anaesthetics, Emergency Medicine or General Surgery as these doctors may be expected to complete a surgical cricothyroidotomy despite infrequently performing the procedure.
- The healthcare professionals can be from Foundation Year 1 to before Certificates of Completion of Training (CCT). Those who are out of training and are not yet at consultant level are also eligible.
- Able to provide informed consent.
Key exclusion criteria (1 listed)
- Healthcare professionals who already complete surgical airways on a regular basis (e.g. Ear Nose Throat or Maxillofacial trainees) as these doctors may already be competent prior to training.
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 |
|---|---|---|
| Porcine modelparticipants to conduct training on porcine model | Other | Porcine Group |
| Synthetic modelparticipants to conduct training on synthetic model | Other | Synthetic |
Primary outcome
Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
Time frame: 1 day
time
2 secondary outcomes
Success rate for cricothyroidotomy
Time frame: 1 day
Complication rate for cricothyroidotomy
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No. no plan
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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.
Michael Helme principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine model and Synthetic model in people with Airway Obstruction, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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: withdrawn, as of the sponsor's last update on 14 Aug 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen. (time frame: 1 day). 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 14 Aug 2019.