UltrasoundNCT05974540
USG vs Palpation for Cricothyroid Membrane Determination
An observational study of Ultrasound and Cricothyroid Membrane, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Ultrasound, Cricothyroid Membrane
- What is being tested?
- Determination of cricothyroid membrane
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- American Society of Anaesthesiologists (ASA) I and II physical status
- Elective pediatric surgery
- Patients going to be intubated
Who cannot join
- ASA III or above physical status
- Emergency surgery
- Patients having tracheostomy
- Patients going to have laryngeal mask
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Department of Anesthesiology and Reanimation
Istanbul, 34912
About this study
Official title: 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.
- Conditions
- Ultrasound, Cricothyroid Membrane
- Being tested
- Determination of cricothyroid membrane
- Keywords
- Cricothyrotomy, Palpation, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of cricothyroid membraneDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the 1 day of the surgery. After the anesthesia induction and intubation.
Secondary outcomes (3)
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.
Measured: On the 1 day of the surgery. After the anesthesia induction and intubation.
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.
Measured: On the 1 day of the surgery. After the anesthesia induction and intubation.
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.
Measured: On the 1 day of the surgery. After the anesthesia induction and intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jul 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
- Investigators
- Ruslan Abdullayev, Principal investigator, Marmara University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974540
- Sponsor's protocol ID
- 09.2023.605
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Versus Physical Examination for Cricothyroid Membrane Determination in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05974540
- Acronym / sponsor ID
- 09.2023.605
- Conditions
- Ultrasound, Cricothyroid Membrane
- Keywords
- Cricothyrotomy, Palpation, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists (ASA) I and II physical status
- Elective pediatric surgery
- Patients going to be intubated
Key exclusion criteria (4 listed)
- ASA III or above physical status
- Emergency surgery
- Patients having tracheostomy
- Patients going to have laryngeal mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of cricothyroid membraneAfter 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. | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
Cricothyroid membrane length
Time frame: 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.
Distance between cricoid cartilage and 2nd tracheal ring
Time frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruslan Abdullayev principal investigator
Marmara University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Cricothyroid Membrane, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.