UltrasonographicNCT06667921
Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery
An observational study of Ultrasonographic and Airway, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the diagnostic accuracy of ultrasonographic airway examination in predicting difficult laryngoscopy in pediatric patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Ultrasonographic, Airway, Difficult Laryngoscopy
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 308 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2024to 1 Sep 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: This prospective observational study will be carried out on 308 children of both genders, American Society of Anesthesiology (ASA) physical status I or II, who will be prepared for elective surgery under general anaesthesia with tracheal intubation.
Who may be able to join
- Children aged (2-5) years old.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I or II.
- Undergoing elective surgery under general anaesthesia with endotracheal intubation.
Who cannot join
- Maxillofacial trauma
- Large mass.
- Scar under the chin.
- History of neck surgery or congenital anomalies of the head and neck as difficult intubation is expected in these cases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed M Abo Farrag, Master, 00201010632778, m.farrag1990@gmail.com
Nabil A Elsheikh, MD
About this study
Official title: The Diagnostic Efficacy of Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery; A Prospective Observational Study
This study aims to evaluate the diagnostic accuracy of ultrasonographic airway examination in predicting difficult laryngoscopy in pediatric patients undergoing elective surgery.
Read the detailed description
A difficult airway in a paediatric patient can be a stressful situation for anaesthesiologists as the most common causes of anaesthesia-related deaths were the result of difficult intubation, which is a more common problem in children than in adults.
Ultrasonography is a valuable, promising tool for preoperative airway evaluation through identifying important son anatomy of the upper airway, such as epiglottis, thyroid cartilage, and vocal cords.
Many studies have shown that some ultrasonic parameters can predict difficult airways in adults, such as tongue thickness, hyomental distance in the extended position (HMDE), distance from skin to epiglottis (DSE), tongue volume, midsagittal tongue cross-sectional area (TCSA), and tongue width. However, whether these parameters can be used to predict difficult laryngoscopy in children is unclear and needs extensive studies
- Conditions
- Ultrasonographic, Airway, Difficult Laryngoscopy, Pediatric, Elective Surgery
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonographic group | Ultrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE). Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultrasound measurement of hyomental distance ratio (HMDR)
Accuracy of ultrasound measurement of hyomental distance ratio (HMDR) in predicting difficult laryngoscopy will be recorded
Measured: 10 minutes till placement of endotracheal tube
Secondary outcomes (2)
Accuracy of ultrasound measurement of distance from skin to epiglottis (DSE)
Accuracy of ultrasound measurement of distance from skin to epiglottis (DSE) in predicting difficult laryngoscopy
Measured: 10 minutes till placement of endotracheal tube
Correlation between the pre-anaesthetic ultrasonographic airway assessment, hyomental distance ratio (HMDR) and distance from skin to epiglottis (DSE)
Correlation between the pre-anaesthetic ultrasonographic airway assessment, hyomental distance ratio (HMDR) and distance from skin to epiglottis (DSE), with the modified Cormack-Lehane grade of direct laryngoscopic view under general anaesthesia.
The laryngoscopic view of the patient's airway will be graded using the Modified Cormack and Lehane grading scale; grades 1 and 2 are considered easy laryngoscopy, and grades 3 and 4 are considered difficult laryngoscopy.
Grade 1: the whole glottis is visible. Grade 2: part of the cords is visible. Grade 3: only epiglottis is visible. Grade 4: epiglottis isn't visible.
Measured: 10 minutes till placement of endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start31 Oct 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographicStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mostafa El-Sayed Abo Farrag, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667921
- Sponsor's protocol ID
- 36265MD172/11/23
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Efficacy of Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery; A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06667921
- Acronym / sponsor ID
- 36265MD172/11/23
- Conditions
- Ultrasonographic, Airway, Difficult Laryngoscopy, Pediatric, Elective Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
This study aims to evaluate the diagnostic accuracy of ultrasonographic airway examination in predicting difficult laryngoscopy in pediatric patients undergoing elective surgery.
Detailed description
A difficult airway in a paediatric patient can be a stressful situation for anaesthesiologists as the most common causes of anaesthesia-related deaths were the result of difficult intubation, which is a more common problem in children than in adults.
Ultrasonography is a valuable, promising tool for preoperative airway evaluation through identifying important son anatomy of the upper airway, such as epiglottis, thyroid cartilage, and vocal cords.
Many studies have shown that some ultrasonic parameters can predict difficult airways in adults, such as tongue thickness, hyomental distance in the extended position (HMDE), distance from skin to epiglottis (DSE), tongue volume, midsagittal tongue cross-sectional area (TCSA), and tongue width. However, whether these parameters can be used to predict difficult laryngoscopy in children is unclear and needs extensive studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonographic group | – | Device: UltrasoundUltrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This prospective observational study will be carried out on 308 children of both genders, American Society of Anesthesiology (ASA) physical status I or II, who will be prepared for elective surgery under general anaesthesia with tracheal intubation.
Key inclusion criteria (4 listed)
- Children aged (2-5) years old.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I or II.
- Undergoing elective surgery under general anaesthesia with endotracheal intubation.
Key exclusion criteria (4 listed)
- Maxillofacial trauma
- Large mass.
- Scar under the chin.
- History of neck surgery or congenital anomalies of the head and neck as difficult intubation is expected in these cases.
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 |
|---|---|---|
| UltrasoundUltrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE). | Device | Ultrasonographic group |
Primary outcome
Accuracy of ultrasound measurement of hyomental distance ratio (HMDR)
Time frame: 10 minutes till placement of endotracheal tube
Accuracy of ultrasound measurement of hyomental distance ratio (HMDR) in predicting difficult laryngoscopy will be recorded
2 secondary outcomes
Accuracy of ultrasound measurement of distance from skin to epiglottis (DSE)
Time frame: 10 minutes till placement of endotracheal tube
Correlation between the pre-anaesthetic ultrasonographic airway assessment, hyomental distance ratio (HMDR) and distance from skin to epiglottis (DSE)
Time frame: 10 minutes till placement of endotracheal tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Ultrasonographic and Airway, run by Tanta 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 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed M Abo Farrag, Master (00201010632778, m.farrag1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ultrasound measurement of hyomental distance ratio (HMDR) (time frame: 10 minutes till placement of endotracheal tube). 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 1 Nov 2024.