NCT05974540

Brief Summary

Emergency cricothyroidotomy is a very important technique to ensure airway safety in acute situations. Problem in identifying the cricothyroid membrane is a major contributor to high failure, as the most common complication during cricothyrotomy is the misplacement of the cannula. The success rate of emergency airway access performed by anesthesiologists and emergency medicine specialists was found to be low due to the low frequency of the procedure. The aim in this study is to compare the palpation method with the ultrasonugraphy (USG)-based method in determining the cricothyroid membrane. The hypothesis is that USG is more successful than palpation in identifying the cricothyroid membrane. In addition, the relationship between difficult intubation and measurements such as the cricothyroid membrane length, the cricoid cartilage and the skin distance, the distance between the cricoid cartilage and the second tracheal ring will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

June 4, 2025

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

July 26, 2023

Last Update Submit

May 29, 2025

Conditions

Keywords

CricothyrotomyPalpationUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Distance between palpation-based and USG-based determination of the cricothyroid membrane

    Regarding the determination point of the cricothyroid membrane the distance between palpation-based method performed by pediatric surgeon and USG-based method performed by anesthesiologist will be measured.

    On the 1 day of the surgery. After the anesthesia induction and intubation.

Secondary Outcomes (3)

  • Cricothyroid membrane length

    On the 1 day of the surgery. After the anesthesia induction and intubation.

  • Skin distance from cricoid cartilage

    On the 1 day of the surgery. After the anesthesia induction and intubation.

  • Distance between cricoid cartilage and 2nd tracheal ring

    On the 1 day of the surgery. After the anesthesia induction and intubation.

Interventions

After the patient's head is extended, the pediatric surgeon will be asked to mark the cricothyroid membrane with a pencil using traditional inspection and palpation methods. Then, the cricothyroid membrane will be determined by the Anesthesiology and Reanimation specialist by USG method and the difference will be determined. Demographic and morphometric characteristics of the patients will be recorded. In addition, the length of the cricothyroid membrane, the distance between the cricoid cartilage and the skin, the distance between the cricoid cartilage and the 2nd tracheal ring will be measured by USG. Mallampati classes of patients with intubation, Cormack-Lehane (CL) glottic appearance grades, Likert scale with intubation difficulties (1: very easy, 2: easy, 3: medium, 4: difficult) will also be recorded.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients between the ages of 1-18, who are in ASA I-II physical status and who will undergo elective surgery under general anesthesia by the Pediatric Surgery at Marmara University Pendik Training and Research Hospital will be included in the study.

You may qualify if:

  • American Society of Anaesthesiologists (ASA) I and II physical status
  • Elective pediatric surgery
  • Patients going to be intubated

You may not qualify if:

  • ASA III or above physical status
  • Emergency surgery
  • Patients having tracheostomy
  • Patients going to have laryngeal mask

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Department of Anesthesiology and Reanimation

Istanbul, 34912, Turkey (Türkiye)

Location

Study Officials

  • Ruslan Abdullayev

    Marmara University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

July 1, 2023

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

June 4, 2025

Record last verified: 2024-08

Locations