Emergent CricothyrodotomyNCT03196752
Laryngeal Handshake for Identifying the Cricothyroid Membrane
A study testing laryngeal handshake and simple palpation in people with Emergent Cricothyrodotomy, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The cricothyroid membrane is the most common position that the invasive airway secure is performed, but it is not easy to identify the cricothyroid membrane by tactile perception. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Emergent Cricothyrodotomy
- What is being tested?
- laryngeal handshake and simple palpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Apr 2017to 30 Dec 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent nose or ear surgery in Seoul National University Hospital and Seoul Metropolitan Government Seoul National University Boramae Medical Center
Who cannot join
- those whose ASA class was over 3, those who rejected to participate study or had impaired capacity to agree, those who was going to undergo neck surgery, those who had anatomical anomaly or skin lesion at neck, and those who were pregnant were excluded.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, Agree, 110-744
Boramae Medical Center
Seoul, 156-707
About this study
Official title: Utility of the Laryngeal Handshake Method for Identifying the Cricothyroid Membrane
The cricothyroid membrane is the most common position that the invasive airway secure is performed, but it is not easy to identify the cricothyroid membrane by tactile perception. Although it is recommended to use the laryngeal handshake method for identifying the cricothyroid membrane in difficult airway society 2015 guidelines for management of unanticipated difficult intubation in adults, there is only suggestion without clinical data about how much the laryngeal handshake method improves the accuracy of identification of the cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified more correctly when the laryngeal handshake method is used than when that method is not used. And we try to find out whether there is actual difference about identification of the cricothyroid membrane between using the laryngeal handshake method and not using that method. By identifying the difference between them, we are going to support the recommendation of guidelines and make the evidence for educating the doctors who have any possibility to perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot intubate, cannot oxygenate' situation.
- Conditions
- Emergent Cricothyrodotomy
- Being tested
- laryngeal handshake, simple palpation
- Keywords
- cricothyroid membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal handshakeProcedure or surgery
palpate for the cricothyroid membrane using the laryngeal handshake technique
simple palpationOther
conventional
| Study group | Role | What they receive |
|---|---|---|
| Only arm | Experimental | Patient's cricoid membrane is identified using both laryngeal handshake method and simple palpation Receives: Procedure: laryngeal handshake; Other: simple palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of cricothyroid membrane identification
accuracy between conventional identification of the cricothyroid membrane and the laryngeal handshake method
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start20 Apr 2017
- Primary completion30 Oct 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergent CricothyrodotomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196752
- Sponsor's protocol ID
- 1704-035-844
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh H, Yoon S, Seo M, Oh E, Yoon H, Lee H, Lee J, Ryu HG. Utility of the laryngeal handshake method for identifying the cricothyroid membrane. Acta Anaesthesiol Scand. 2018 Oct;62(9):1223-1228. doi: 10.1111/aas.13169. Epub 2018 Jun 21.
PubMed 29926892
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Laryngeal Handshake Method for Identifying the Cricothyroid Membrane
- ClinicalTrials.gov ID
- NCT03196752
- Acronym / sponsor ID
- 1704-035-844
- Conditions
- Emergent Cricothyrodotomy
- Keywords
- cricothyroid membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 23 Jun 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.
The cricothyroid membrane is the most common position that the invasive airway secure is performed, but it is not easy to identify the cricothyroid membrane by tactile perception. Although it is recommended to use the laryngeal handshake method for identifying the cricothyroid membrane in difficult airway society 2015 guidelines for management of unanticipated difficult intubation in adults, there is only suggestion without clinical data about how much the laryngeal handshake method improves the accuracy of identification of the cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified more correctly when the laryngeal handshake method is used than when that method is not used. And we try to find out whether there is actual difference about identification of the cricothyroid membrane between using the laryngeal handshake method and not using that method. By identifying the difference between them, we are going to support the recommendation of guidelines and make the evidence for educating the doctors who have any possibility to perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot intubate, cannot oxygenate' situation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only arm | Experimental | Procedure: laryngeal handshake, Other: simple palpationPatient's cricoid membrane is identified using both laryngeal handshake method and simple palpation |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent nose or ear surgery in Seoul National University Hospital and Seoul Metropolitan Government Seoul National University Boramae Medical Center
Key exclusion criteria (1 listed)
- those whose ASA class was over 3, those who rejected to participate study or had impaired capacity to agree, those who was going to undergo neck surgery, those who had anatomical anomaly or skin lesion at neck, and those who were pregnant were excluded.
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 |
|---|---|---|
| laryngeal handshakepalpate for the cricothyroid membrane using the laryngeal handshake technique | Procedure or surgery | Only arm |
| simple palpationconventional | Other | Only arm |
Primary outcome
accuracy of cricothyroid membrane identification
Time frame: Baseline
accuracy between conventional identification of the cricothyroid membrane and the laryngeal handshake method
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 25 Jan 2018.
- Derived from this study: PubMed 29926892Oh H, Yoon S, Seo M, Oh E, Yoon H, Lee H, Lee J, Ryu HG. Utility of the laryngeal handshake method for identifying the cricothyroid membrane. Acta Anaesthesiol Scand. 2018 Oct;62(9):1223-1228. doi: 10.1111/aas.13169. Epub 2018 Jun 21.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal handshake and simple palpation in people with Emergent Cricothyrodotomy, run by Seoul National University Hospital at 2 sites 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 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 25 Jan 2018. 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 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?
accuracy of cricothyroid membrane identification (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196752, which also lists 1 linked publication.
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 25 Jan 2018.