Airway Ultrasound IndicesNCT07185516
Airway Ultrasound Indices for Prediction of Difficult Laryngoscopy in Pediatric Patients
An observational study of Airway Ultrasound Indices and Clinical Airway Assessment, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this observational study is to compare the airway ultrasound indices and the preoperative clinical airway assessment concerning the difficult laryngoscopic view in paediatric patients undergoing elective surgery under general anaesthesia The main question it aims to answer is: Do airway ultrasound indices… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Ultrasound Indices, Clinical Airway Assessment
- What is being tested?
- Airway ultrasound indices and Clinical airway assessment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric patients aged 7 to 12 years old of both sexes undergoing elective surgery under general anaesthesia
Who may be able to join
- ASA Class I and II.
- Patients undergoing elective surgery under general anaesthesia
Who cannot join
- Congenital upper airway malformation.
- Head and neck swellings.
- Scars.
- Radiation to the neck.
- Tracheotomy.
- Neurosurgical or cardiac procedures.
- ENT surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Airway Ultrasound Indices Versus Clinical Assessment for Prediction of Difficult Laryngoscopy in Elective Surgical Pediatric Patients
The goal of this observational study is to compare the airway ultrasound indices and the preoperative clinical airway assessment concerning the difficult laryngoscopic view in paediatric patients undergoing elective surgery under general anaesthesia
The main question it aims to answer is:
- Do airway ultrasound indices better predict difficult laryngoscopic view in paediatric patients than clinical airway assessment?
Read the detailed description
Airway-related morbidity, as a result of an inability to anticipate a difficult airway, remains the primary concern for an anesthesiologist. Various clinical measurements and methods, such as the thyromental distance (TMD), sternomental distance, horizontal length of the mandible, head and neck movement, and the Mallampati score, were used to predict difficult laryngoscopy and intubation in adult patients. However, using these measurements in the pediatric population is not as easy as in adults.
The use of airway sonography has been extended as an assessment tool for a difficult airway. Various parameters like tongue thickness, anterior soft tissue thickness, and hyomental distance ratio have been used to predict a difficult airway. However, the usefulness of ultrasonography to predict a difficult airway in infants and children has still not been described. This study will compare the effectiveness of clinical measurements to the ultrasound indices in predicting difficult laryngoscopic view in paediatric patients.
- Being tested
- Airway ultrasound indices, Clinical airway assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway ultrasound indicesOther
Tongue thickness, hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), ratio of hyomental distance in both positions (HMDR), thyromental distance (TMD), ratio of tongue thickness to thyromental distance (TT/TMD), epiglottis thickness \&pre-epiglottic space thickness
Clinical airway assessmentOther
Mallampati grading and thyromental distance (TMD). The glottic structures displayed during laryngoscopy will be classified according to the Cormack-Lehane
| Study group | Role | What they receive |
|---|---|---|
| Airway assessment | clinical and ultrasound assessment of the airway Receives: Other: Airway ultrasound indices; Other: Clinical airway assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence rate of difficult intubation
failure to intubate the patient within 60 seconds
Measured: 60 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Ultrasound IndicesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
- Investigators
- Rania M Hussien, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185516
- Sponsor's protocol ID
- FMASU MD57/2023
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Ultrasound Indices Versus Clinical Assessment for Prediction of Difficult Laryngoscopy in Elective Surgical Pediatric Patients
- ClinicalTrials.gov ID
- NCT07185516
- Acronym / sponsor ID
- FMASU MD57/2023
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Sep 2025 (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.
The goal of this observational study is to compare the airway ultrasound indices and the preoperative clinical airway assessment concerning the difficult laryngoscopic view in paediatric patients undergoing elective surgery under general anaesthesia
The main question it aims to answer is:
- Do airway ultrasound indices better predict difficult laryngoscopic view in paediatric patients than clinical airway assessment?
Detailed description
Airway-related morbidity, as a result of an inability to anticipate a difficult airway, remains the primary concern for an anesthesiologist. Various clinical measurements and methods, such as the thyromental distance (TMD), sternomental distance, horizontal length of the mandible, head and neck movement, and the Mallampati score, were used to predict difficult laryngoscopy and intubation in adult patients. However, using these measurements in the pediatric population is not as easy as in adults.
The use of airway sonography has been extended as an assessment tool for a difficult airway. Various parameters like tongue thickness, anterior soft tissue thickness, and hyomental distance ratio have been used to predict a difficult airway. However, the usefulness of ultrasonography to predict a difficult airway in infants and children has still not been described. This study will compare the effectiveness of clinical measurements to the ultrasound indices in predicting difficult laryngoscopic view in paediatric patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway assessment | – | Other: Airway ultrasound indices, Other: Clinical airway assessmentclinical and ultrasound assessment of the airway |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric patients aged 7 to 12 years old of both sexes undergoing elective surgery under general anaesthesia
Key inclusion criteria (2 listed)
- ASA Class I and II.
- Patients undergoing elective surgery under general anaesthesia
Key exclusion criteria (7 listed)
- Congenital upper airway malformation.
- Head and neck swellings.
- Scars.
- Radiation to the neck.
- Tracheotomy.
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 |
|---|---|---|
| Airway ultrasound indicesTongue thickness, hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), ratio of hyomental distance in both positions (HMDR), thyromental distance (TMD), ratio of tongue thickness to thyromental distance (TT/TMD), epiglottis thickness \&pre-epiglottic space thickness | Other | Airway assessment |
| Clinical airway assessmentMallampati grading and thyromental distance (TMD). The glottic structures displayed during laryngoscopy will be classified according to the Cormack-Lehane | Other | Airway assessment |
Primary outcome
Prevalence rate of difficult intubation
Time frame: 60 Seconds
failure to intubate the patient within 60 seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Airway Ultrasound Indices
RecruitingObservational study
Ultrasonographical Assessment of Airway Indices in Pregnancy
Airway Assessment
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.
Rania M Hussien principal investigator
Ain Shams University
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 Airway Ultrasound Indices and Clinical Airway Assessment, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence rate of difficult intubation (time frame: 60 Seconds). 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 22 Sep 2025.