USG vs Palpation for Cricothyroid Membrane Determination

Ultrasound Clinical Trial

Official title:

Ultrasound Versus Physical Examination for Cricothyroid Membrane Determination in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974540
• Other study ID #: 09.2023.605
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Marmara University
• Contact: Ruslan Abdullayev
• Phone: +905063010833
• Email: ruslan_jnr[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cricothyroid Membrane
• Ultrasound

Intervention

Diagnostic Test:
• Determination of cricothyroid membrane
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.

Locations

Country	Name	City	State
Turkey	Marmara University Department of Anesthesiology and Reanimation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cricothyroid membrane length	Cricothyroid membrane length will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.	On the 1 day of the surgery. After the anesthesia induction and intubation.
Secondary	Skin distance from cricoid cartilage	Skin distance from cricoid cartilage will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.	On the 1 day of the surgery. After the anesthesia induction and intubation.
Secondary	Distance between cricoid cartilage and 2nd tracheal ring	Distance between cricoid cartilage and 2nd tracheal ring will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.	On the 1 day of the surgery. After the anesthesia induction and intubation.