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Laryngeal Handshake for Identifying the Cricothyroid Membrane

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ClinicalTrials.gov Identifier: NCT03196752
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ho Geol Ryu, Seoul National University Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Emergent Cricothyrodotomy Procedure: laryngeal handshake Other: simple palpation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Utility of the Laryngeal Handshake Method for Identifying the Cricothyroid Membrane
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : December 30, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Only arm
Patient's cricoid membrane is identified using both laryngeal handshake method and simple palpation
 Procedure: laryngeal handshake
palpate for the cricothyroid membrane using the laryngeal handshake technique

Other: simple palpation
conventional


Outcome Measures
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Primary Outcome Measures :
  1. accuracy of cricothyroid membrane identification [ Time Frame: Baseline ]
    accuracy between conventional identification of the cricothyroid membrane and the laryngeal handshake method


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196752


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Agree, Korea, Republic of, 110-744
Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ho Geol Ryu, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03196752    
Other Study ID Numbers: 1704-035-844
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ho Geol Ryu, Seoul National University Hospital:
cricothyroid membrane