NCT05043025

Brief Summary

Cricothyroidotomy is an emergency rescue technique to secure the airway in a 'Can't intubate, Can't Oxygenate' (CICO) situation. The cricothyroid membrane (CTM) is the target site of cricothyroidotomy, and accurate identification of the CTM is essential for successful cricothyroidotomy. In this study, the investigators compare patient positions (neck extension vs. modified ramped position) in terms of the success rate for identifying the CTM in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration 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 31, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

August 31, 2021

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success rate for the correct identification of the cricothyroid membrane

    After identifying the cricothyroid membrane using a laryngeal handshake technique in different head positions, an assessor evaluates the correctness of its localization using ultrasound.

    Immediately after identifying the cricothyroid membrane using a laryngeal handshake technique

Secondary Outcomes (3)

  • Duration for identifying the cricothyroid membrane

    At 90 seconds after administering neuromuscular blockade

  • Distances between the center of the actual and perceived cricothyroid membrane

    Immediately after identifying the cricothyroid membrane using a laryngeal handshake technique

  • Perceived difficulty during cricothyroid membrane identification

    At 5 minutes after identifying the cricothyroid membrane using a laryngeal handshake technique

Study Arms (2)

Neck extension group

ACTIVE COMPARATOR

The cricothyroid membrane is identified in a neck extended position.

Other: Identification of the cricothyroid membrane

Modified ramped position group

EXPERIMENTAL

The cricothyroid membrane is identified in a modified ramped position.

Other: Identification of the cricothyroid membrane

Interventions

The cricothyroid membrane is identified using a laryngeal handshake technique in different patient positions.

Modified ramped position groupNeck extension group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index \>30 kg/m2

You may not qualify if:

  • anatomical abnormalities or pathologies of the neck
  • a history of neck surgery
  • cervical spine disorders
  • skin lesions on the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, Select State/Province, 07061, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 13, 2021

Study Start

July 1, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations