NCT04065412

Brief Summary

In this study, we compare the conventional laryngeal handshake technique and modified laryngeal handshake technique for locating the cricothyroid membrane in terms of accuracy and speed. The conventional laryngeal handshake technique is performed with the non-dominant hand, identifying the hyoid bone and thyroid laminae, stabilizing the larynx between thumb and middle finger, and moving down the neck to palpate the cricothyroid membrane with the index finger. The modified laryngeal handshake is performed with the non-dominant hand, stabilizing the trachea between thumb and middle finger from the suprasternal notch and moving up the neck to palate the cricoid cartilage and cricothyroid membrane with the index finger.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

August 21, 2019

Last Update Submit

January 25, 2021

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • The accuracy to localize the cricothyoid membrane

    The accuracy of the cricothyroid membrane identified by the conventional and modified handshake techniques are evaluated.

    1 minute after identifying the cricothyroid membrane using the conventional or modified laryngeal handshake technique

Secondary Outcomes (3)

  • The accuracy to localize the midline of the neck

    through the identification of cricothyroid membrane, an average of 5 minutes

  • The vertical and horizontal distances between the actual and perceived cricothyroid membrane

    through the identification of cricothyroid membrane, an average of 5 minutes

  • Time to localize the cricothyroid membrane

    through the identification of cricothyroid membrane, an average of 5 minutes

Study Arms (2)

Conventional laryngeal handshake technique

ACTIVE COMPARATOR

The conventional laryngeal handshake technique is performed to localize the cricothyroid membrane

Procedure: Conventional laryngeal handshake technique

Modified laryngeal handshake technique

EXPERIMENTAL

The modified laryngeal handshake is performed to localize the cricothyroid membrane

Procedure: Modified laryngeal handshake technique

Interventions

Conventional laryngeal handshake techniquePROCEDURE

The conventional laryngeal handshake technique is performed with the non-dominant hand, identifying the hyoid bone and thyroid laminae, stabilizing the larynx between thumb and middle finger, and moving down the neck to palpate the cricothyroid membrane with the index finger.

Conventional laryngeal handshake technique
Modified laryngeal handshake techniquePROCEDURE

The modified laryngeal handshake is performed with the non-dominant hand, stabilizing the trachea between thumb and middle finger from the suprasternal notch and moving up the neck to palate the cricoid cartilage and cricothyroid membrane with the index finger.

Modified laryngeal handshake technique

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who would be scheduled elective surgery under general anesthesia

You may not qualify if:

  • Diseases or anatomical abnormalities in the neck or larynx
  • History of neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Chang JE, Kim H, Won D, Lee JM, Kim TK, Min SW, Hwang JY. Comparison of the Conventional Downward and Modified Upward Laryngeal Handshake Techniques to Identify the Cricothyroid Membrane: A Randomized, Comparative Study. Anesth Analg. 2021 Nov 1;133(5):1288-1295. doi: 10.1213/ANE.0000000000005744.

    PMID: 34517392DERIVED

Study Officials

  • Jin-Young Hwang, MD, PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 22, 2019

Study Start

March 5, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

KR(1)