Airway ObstructionNCT02975791
Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane
A study testing Marking the cricothyroid membrane after ultrasound and Marking of the cricothyroid membrane after Palpation in people with Airway Obstruction, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation. In an obese volunteer Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Marking the cricothyroid membrane after ultrasound and Marking of the cricothyroid membrane after Palpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 40
- Female
Who cannot join
- Age below 18
About this study
After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation. In an obese volunteer
Read the detailed description
After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation.
The purpose is to advise a propriety method for preanesthetic identification. In an obese volunteer
- Conditions
- Airway Obstruction
- Being tested
- Marking the cricothyroid membrane after ultrasound, Marking of the cricothyroid membrane after Palpation
- Keywords
- Airway Obstruction
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marking the cricothyroid membrane after ultrasoundOther
Ultrasonography is applied to the subjects neck in order to identify the cricothyroid membrane - subsequently the membrane is marked with a pen
Marking of the cricothyroid membrane after PalpationProcedure or surgery
Palpation is applied to the subjects neck in order to identify the cricothyroid membrane- subsequently the membrane is marked with a pen
| Study group | Role | What they receive |
|---|---|---|
| palpation | Active comparator | Marking the cricothyroid membrane after ultrasound
The intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy. The doctors mark the cricothyroid membrane with a pen after using palpation for identification. Receives: Procedure: Marking of the cricothyroid membrane after Palpation |
| ultrasound | Active comparator | Marking of the cricothyroid membrane after Palpation
intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy doctors mark the cricothyroid membrane with a pen after using ultrasonography for the identification Receives: Other: Marking the cricothyroid membrane after ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of correct identification of the cricothyroid membrane
The fraction of cases where the cricothyroid membrane is identified correctly
Measured: "2 min"
Secondary outcomes (1)
time to correct identification of the cricothyroid membrane
The time consumed for correct identification of the cricothyroid membrane
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 posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975791
- Sponsor's protocol ID
- Ultrasound MC 24112016
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane
- ClinicalTrials.gov ID
- NCT02975791
- Acronym / sponsor ID
- Ultrasound MC 24112016
- Conditions
- Airway Obstruction
- Keywords
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 29 Nov 2016 (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.
After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation. In an obese volunteer
Detailed description
After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation.
The purpose is to advise a propriety method for preanesthetic identification. In an obese volunteer
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palpation | Active comparator | Procedure: Marking of the cricothyroid membrane after PalpationMarking the cricothyroid membrane after ultrasound The intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy. The doctors mark the cricothyroid membrane with a pen after using palpation for identification. |
| ultrasound | Active comparator | Other: Marking the cricothyroid membrane after ultrasoundMarking of the cricothyroid membrane after Palpation intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy doctors mark the cricothyroid membrane with a pen after using ultrasonography for the identification |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 40
- Female
Key exclusion criteria (1 listed)
- Age below 18
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 |
|---|---|---|
| Marking the cricothyroid membrane after ultrasoundUltrasonography is applied to the subjects neck in order to identify the cricothyroid membrane - subsequently the membrane is marked with a pen | Other | ultrasound |
| Marking of the cricothyroid membrane after PalpationPalpation is applied to the subjects neck in order to identify the cricothyroid membrane- subsequently the membrane is marked with a pen | Procedure or surgery | palpation |
Primary outcome
Frequency of correct identification of the cricothyroid membrane
Time frame: "2 min"
The fraction of cases where the cricothyroid membrane is identified correctly
1 secondary outcome
time to correct identification of the cricothyroid membrane
Time frame: "2 min"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Airway Obstruction
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Marking the cricothyroid membrane after ultrasound and Marking of the cricothyroid membrane after Palpation in people with Airway Obstruction, run by Copenhagen University Hospital, Rigshospitalet.
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: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Frequency of correct identification of the cricothyroid membrane (time frame: "2 min"). 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 29 Nov 2016.