Upper Airway ObstructionNCT02613429
Identification of Airway Structures Necessary for Airway Access Via the Skin
A study testing identification of the airway by from the cranial end and identification of the airway from the distal end in people with Upper Airway Obstruction, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation. The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Airway Obstruction
- What is being tested?
- identification of the airway by from the cranial end and identification of the airway from the distal end
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2015to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anaesthesiologist
Who cannot join
- unvillingnes to participate
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, department of anaesthesia
Copenhagen, 2000
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, 2100
About this study
Official title: Identification of Airway Structures Necessary for Airway Access Via the Skin to be Used in Case of Failure to Maintain Oxygenation With Non-invasive Methods
Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.
The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.
Read the detailed description
Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.
The researchers will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage of a healthy subject with different methods including application of ultrasonography.
- Conditions
- Upper Airway Obstruction
- Being tested
- identification of the airway by from the cranial end, identification of the airway from the distal end
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identification of the airway by from the cranial endBehavioural
The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the thyroid cartilage and from there moving distally
identification of the airway from the distal endBehavioural
The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the distal trachea and moving cranially
| Study group | Role | What they receive |
|---|---|---|
| Cranial horizontal | Active comparator | identification of the airway by from the cranial end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination from the cranial end at the level of the thyroid catilage , horizontally and thereafter moving caudally Receives: Behavioral: identification of the airway by from the cranial end |
| caudal longitudinal | Active comparator | identification of the airway from the distal end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination caudally, and then moving cranially Receives: Behavioral: identification of the airway from the distal end |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to identify the structures necessary for percutaneous airway acess
Measured: two minutes after initiation of the attempt to identify the airway structures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael S Kristensen, M.D., Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613429
- Sponsor's protocol ID
- Seventh floor 15/1
- Status last verified
- Jan 2016
- First submitted
- 19 Nov 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Airway Structures Necessary for Airway Access Via the Skin to be Used in Case of Failure to Maintain Oxygenation With Non-invasive Methods
- ClinicalTrials.gov ID
- NCT02613429
- Acronym / sponsor ID
- Seventh floor 15/1
- Conditions
- Upper Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Nov 2015 (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.
Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.
The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.
Detailed description
Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.
The researchers will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage of a healthy subject with different methods including application of ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial horizontal | Active comparator | Behavioral: identification of the airway by from the cranial endidentification of the airway by from the cranial end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination from the cranial end at the level of the thyroid catilage , horizontally and thereafter moving caudally |
| caudal longitudinal | Active comparator | Behavioral: identification of the airway from the distal endidentification of the airway from the distal end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination caudally, and then moving cranially |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anaesthesiologist
Key exclusion criteria (1 listed)
- unvillingnes 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| identification of the airway by from the cranial endThe airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the thyroid cartilage and from there moving distally | Behavioural | Cranial horizontal |
| identification of the airway from the distal endThe airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the distal trachea and moving cranially | Behavioural | caudal longitudinal |
Primary outcome
time to identify the structures necessary for percutaneous airway acess
Time frame: two minutes after initiation of the attempt to identify the airway structures
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 5 Jan 2016.
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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 S Kristensen, M.D. study chair
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing identification of the airway by from the cranial end and identification of the airway from the distal end in people with Upper Airway Obstruction, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 identify the structures necessary for percutaneous airway acess (time frame: two minutes after initiation of the attempt to identify the airway structures). 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 5 Jan 2016.