- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974540
USG vs Palpation for Cricothyroid Membrane Determination
August 4, 2023 updated by: Ruslan Abdullayev, Marmara University
Ultrasound Versus Physical Examination for Cricothyroid Membrane Determination in Pediatric Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruslan Abdullayev
- Phone Number: +905063010833
- Email: ruslan_jnr@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34912
- Recruiting
- Marmara University Department of Anesthesiology and Reanimation
-
Contact:
- Ruslan Abdullayev
- Phone Number: +905063010833
- Email: ruslan_jnr@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance between palpation-based and USG-based determination of the cricothyroid membrane
Time Frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cricothyroid membrane length
Time Frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
|
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.
|
Skin distance from cricoid cartilage
Time Frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
|
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.
|
Distance between cricoid cartilage and 2nd tracheal ring
Time Frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ruslan Abdullayev, Marmara University Department of Anesthesiology and Reanimation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
August 2, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09.2023.605
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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