UltrasoundNCT04457414
Identifying Cricothyroid Membrane With Ultrasound
An observational study of Ultrasound, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ultrasound
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2020to 5 Feb 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients undergoing general anesthesia
Who may be able to join
- pediatric patients undergoing general anesthesia
Who cannot join
- previous history of tracheostomy
- previous history of operation on neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Curve of Inexperienced Trainees for Identifying Cricothyroid Membrane With Ultrasound in Pediatric Patients
Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an instructional video, 30 trainees performed 5 cricothyroid membrane identification on pediatric patients undergoing general anesthesia. We analysed their learning curves relative to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.
- Conditions
- Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance time for identifying cricothyroid membrane with ultrasound
Measured: from immediately after anesthetic induction to end of surgery
Secondary outcomes (1)
ultrasound anatomy of cricothyroid membrane
depth from skin surface, thickness, diameter, relative vessels
Measured: from immediately after anesthetic induction to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start30 Jun 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457414
- Sponsor's protocol ID
- 2005-230-113
- Status last verified
- Feb 2021
- First submitted
- 30 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Inexperienced Trainees for Identifying Cricothyroid Membrane With Ultrasound in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04457414
- Acronym / sponsor ID
- 2005-230-113
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 7 Jul 2020 (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.
Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an instructional video, 30 trainees performed 5 cricothyroid membrane identification on pediatric patients undergoing general anesthesia. We analysed their learning curves relative to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients undergoing general anesthesia
Key inclusion criteria (1 listed)
- pediatric patients undergoing general anesthesia
Key exclusion criteria (2 listed)
- previous history of tracheostomy
- previous history of operation on neck
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
Performance time for identifying cricothyroid membrane with ultrasound
Time frame: from immediately after anesthetic induction to end of surgery
1 secondary outcome
ultrasound anatomy of cricothyroid membrane
Time frame: from immediately after anesthetic induction to end of surgery
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 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 Feb 2021. 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 South Korea. 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 for identifying cricothyroid membrane with ultrasound (time frame: from immediately after anesthetic induction to end of surgery). 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 Feb 2021.