- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196752
Laryngeal Handshake for Identifying the Cricothyroid Membrane
January 23, 2018 updated by: Ho Geol Ryu, Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 156-707
- Boramae Medical Center
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-
Agree
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Seoul, Agree, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who underwent nose or ear surgery in Seoul National University Hospital and Seoul Metropolitan Government Seoul National University Boramae Medical Center
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Only arm
Patient's cricoid membrane is identified using both laryngeal handshake method and simple palpation
|
palpate for the cricothyroid membrane using the laryngeal handshake technique
conventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
accuracy of cricothyroid membrane identification
Time Frame: Baseline
|
accuracy between conventional identification of the cricothyroid membrane and the laryngeal handshake method
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
October 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
June 21, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 23, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1704-035-844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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