UltrasoundNCT06925165
Ultrasound Measured Hyomental Distance to Tongue Thickness Ratio as a Predictor of Difficult Intubation in Infants
An observational study of Ultrasound, run by Ain Shams University at 1 site in Egypt.
Trial summary
Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2025to 29 Jul 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged 1 to 12 months
Who may be able to join
- Infants aged 1 to 12 months
- Both sexes.
- Physical status ASA I or II
Who cannot join
- Restricted mobility of temporomandibular joint
- Absent anesthesia or surgical consent
- Maxillofacial trauma or tumors
- A large mass or scar under the chin
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants
Read the detailed description
Sonographic assessment of the airway after induction of anesthesia and Master Degree Thesis / MFA/ISRO/ Faculty Of Medicine/ASU Page 6 intubation: All infants will be placed in a supine position with their heads slightly extended. Then, the low-frequency probe (curved) will be first placed under the chin in the midsagittal plane and adjusted to show a clear view of the entire tongue outline and the border of the mandible and hyoid bone on the screen. The image will be frozen and stored. On the image the tongue thickness will be measured, which is the maximum vertical distance from the sub mental skin to the tongue surface (Yao W, Wang B 2017). After that, the HMDE will be measured, which is the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone.
- Conditions
- Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants.
Difficult intubation can be a significant life threatening problem in anesthesia which can lead to serious complications like hypoxia, aspiration, esophageal intubation, emergency surgical airway, cardiovascular instability, cardiac arrhythmias, ischemic encephalopathy, and death.
In the study investigators will use hyomental distance and tongue thickness measured by ultrasound to suspect difficult intubation in infants aged 1 to 12 month.
Measured: 2 to 3 minutes after induction of anaesthesia and intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start29 Jan 2025
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Jul 2025 (estimated)
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaimaa Reda Ahmed, MBBCH, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925165
- Sponsor's protocol ID
- FMASU MS 53/2025
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measured Hyomental Distance to Tongue Thickness Ratio as a Predictor of Difficult Intubation in Infants
- ClinicalTrials.gov ID
- NCT06925165
- Acronym / sponsor ID
- FMASU MS 53/2025
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 13 Apr 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.
Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants
Detailed description
Sonographic assessment of the airway after induction of anesthesia and Master Degree Thesis / MFA/ISRO/ Faculty Of Medicine/ASU Page 6 intubation: All infants will be placed in a supine position with their heads slightly extended. Then, the low-frequency probe (curved) will be first placed under the chin in the midsagittal plane and adjusted to show a clear view of the entire tongue outline and the border of the mandible and hyoid bone on the screen. The image will be frozen and stored. On the image the tongue thickness will be measured, which is the maximum vertical distance from the sub mental skin to the tongue surface (Yao W, Wang B 2017). After that, the HMDE will be measured, which is the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged 1 to 12 months
Key inclusion criteria (3 listed)
- Infants aged 1 to 12 months
- Both sexes.
- Physical status ASA I or II
Key exclusion criteria (4 listed)
- Restricted mobility of temporomandibular joint
- Absent anesthesia or surgical consent
- Maxillofacial trauma or tumors
- A large mass or scar under the chin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants.
Time frame: 2 to 3 minutes after induction of anaesthesia and intubation
Difficult intubation can be a significant life threatening problem in anesthesia which can lead to serious complications like hypoxia, aspiration, esophageal intubation, emergency surgical airway, cardiovascular instability, cardiac arrhythmias, ischemic encephalopathy, and death. In the study investigators will use hyomental distance and tongue thickness measured by ultrasound to suspect difficult intubation in infants aged 1 to 12 month.
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 13 Apr 2025.
- Individual participant dataSharing planned: Yes. all data will be shared once study is completed
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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.
Shaimaa Reda Ahmed, MBBCH principal investigator
Anesthesia resident 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 Ultrasound, 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants. (time frame: 2 to 3 minutes after induction of anaesthesia 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 13 Apr 2025.