Airway Complication of AnesthesiaAirwayUSNCT06892405
Airway US in Predicting Difficult Pediatric Laryngoscopy
An observational study of Airway Complication of Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- SonoSite™ S Series ultrasound
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 1 May 2027
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-6 years, ASA I, II who will be scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.
Who may be able to join
- Gender both males and females
- ASA Class I and II
- Age 2 years to 6
- Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.
Who cannot join
- Congenital upper airway malformation,
- Head and neck swellings,
- Scars,
- Radiation to the neck,
- Tracheotomy,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karim A Hamoda, MBBCH contact
Egypt1 site
Assiut university Pediatric hospital
Asyut, Assiut Governorate, 715715
Hala S Abdel-Ghaffar, MD, +2 01003812011, hallasaad@yahoo.com
Karim A Hamouda, MBBCH, 01148066608
About this study
Official title: Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.
The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.
Read the detailed description
Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).
- Conditions
- Airway Complication of Anesthesia
- Being tested
- SonoSite™ S Series ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoSite™ S Series ultrasoundDevice
Also called US
US measurements will be performed in the pre-operating room a
, patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords).
To evaluate the accuracy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Namely the DSH, DSE, DSG, DSH+DSE, and DSH-DSE in prediction of difficult laryngoscopy.
Measured: Preoperative
Secondary outcomes (3)
The Modified Mallampati Score (MMS).
The Modified Mallampati Score (MMS):
- Class I: Soft palate, uvula, fauces, pillars visible.
- Class II: Soft palate, major part of uvula, fauces visible.
- Class III: Soft palate, base of uvula visible.
- Class IV: Only hard palate visible.
Measured: At Intubation
The thyromental distance (TMD)
The thyromental distance (TMD) is the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended measured by a ruler.
Measured: preoperative
The upper lip bite test (ULBT)
The upper lip bite test (ULBT) performed by an anesthesiologist associated with this research and a specialist with more than 10 years of experience and in charge of the operating room.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892405
- Sponsor's protocol ID
- 04-2024-201007
- Acronym
- AirwayUS
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.
- ClinicalTrials.gov ID
- NCT06892405
- Acronym / sponsor ID
- AirwayUS / 04-2024-201007
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Mar 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 hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.
Detailed description
Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-6 years, ASA I, II who will be scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class I and II
- Age 2 years to 6
- Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.
Key exclusion criteria (5 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 |
|---|---|---|
| SonoSite™ S Series ultrasoundAlso: USUS measurements will be performed in the pre-operating room a , patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly. | Device | – |
Primary outcome
prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords).
Time frame: Preoperative
To evaluate the accuracy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Namely the DSH, DSE, DSG, DSH+DSE, and DSH-DSE in prediction of difficult laryngoscopy.
3 secondary outcomes
The Modified Mallampati Score (MMS).
Time frame: At Intubation
The thyromental distance (TMD)
Time frame: preoperative
The upper lip bite test (ULBT)
Time frame: Preoperative
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 24 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Karim A Hamoda, MBBCH contact
Hala S Abdel-Ghaffar, MD principal investigator
Assiut 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 Complication of Anesthesia, run by Assiut 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 5 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: opening soon, as of the sponsor's last update on 24 Mar 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?
Contact Hala S Abdel-Ghaffar, MD (01003812011 ext. +20, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). (time frame: Preoperative). 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 24 Mar 2025.