Skip to content

Airway US in Predicting Difficult Pediatric Laryngoscopy

Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06892405
Acronym
AirwayUS
Enrollment
49
Registered
2025-03-24
Start date
2025-04-20
Completion date
2027-05-01
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia

Brief 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 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).

Interventions

DEVICESonoSite™ S Series ultrasound

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Congenital upper airway malformation, * Head and neck swellings, * Scars, * Radiation to the neck, * Tracheotomy,

Design outcomes

Primary

MeasureTime frameDescription
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).PreoperativeTo 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.

Secondary

MeasureTime frameDescription
The Modified Mallampati Score (MMS).At IntubationThe 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.
The thyromental distance (TMD)preoperativeThe 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.
The upper lip bite test (ULBT)PreoperativeThe 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.

Countries

Egypt

Contacts

Primary ContactHala S Abdel-Ghaffar, MD
hallasaad@yahoo.com01003812011
Backup ContactKarim A Hamoda, MBBCH
01148066608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026