Airway ManagementNCT00951769
Algorithms in a Simulated Difficult Intubation Scenario
An observational study of Airway Management, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a non-human study, conducted in a simulation environment, with simulator manikins, and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training will be randomised to a control group, a group following the Difficult Airway Society UK's Guidelines and the Australian Difficult Airway… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Feb 2011
- Phase
- Observational
- 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
Study population: Trainee anaesthetists in for 2 years of training
Who may be able to join
- Anaesthetists in first 2 years of training
Who cannot join
- Those who decline invitation to participate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cheshire & Merseyside Simulation Centre
Liverpool, Merseyside, L9 7AL
About this study
Official title: A Comparison of the Difficult Airway Society (UK) and Australian Patient Safety Foundation Crisis Algorithms for Difficult Intubation in a Simulated Difficult Intubation Scenario
This is a non-human study, conducted in a simulation environment, with simulator manikins, and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training will be randomised to a control group, a group following the Difficult Airway Society UK's Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult airway will be created during the induction of anaesthesia. The investigators will examine adherence to guidelines, which would have been provided to participants before the experiment, as well as compare their performance with the guidelines.
- Conditions
- Airway Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control, | Control | |
| DAS: Difficult Airway Society, UK | DAS difficult airway algorithm | |
| Australian | Australian difficult airway algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to safe oxygenation for manikin
Measured: Variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ARPAN GUHA, MD, FRCA, Principal investigator, AINTREE HOSPITALS NHS TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951769
- Sponsor's protocol ID
- 09/H1001/3
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2009
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Difficult Airway Society (UK) and Australian Patient Safety Foundation Crisis Algorithms for Difficult Intubation in a Simulated Difficult Intubation Scenario
- ClinicalTrials.gov ID
- NCT00951769
- Acronym / sponsor ID
- 09/H1001/3
- Conditions
- Airway Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Aug 2009 (estimated)
- 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 is a non-human study, conducted in a simulation environment, with simulator manikins, and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training will be randomised to a control group, a group following the Difficult Airway Society UK's Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult airway will be created during the induction of anaesthesia. The investigators will examine adherence to guidelines, which would have been provided to participants before the experiment, as well as compare their performance with the guidelines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control, | – | –Control |
| DAS: Difficult Airway Society, UK | – | –DAS difficult airway algorithm |
| Australian | – | –Australian difficult airway algorithm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trainee anaesthetists in for 2 years of training
Key inclusion criteria (1 listed)
- Anaesthetists in first 2 years of training
Key exclusion criteria (1 listed)
- Those who decline invitation to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to safe oxygenation for manikin
Time frame: Variable
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 Jun 2022.
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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.
ARPAN GUHA, MD, FRCA principal investigator
AINTREE HOSPITALS NHS TRUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Liverpool University Hospitals NHS Foundation 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 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 9 Jun 2022. 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 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?
Time to safe oxygenation for manikin (time frame: Variable). 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 9 Jun 2022.