Airway US in Predicting Difficult Pediatric Laryngoscopy

Not yet recruiting

• Conditions: Airway Complication of Anesthesia

• Registration Number: NCT06892405
• Lead Sponsor: Assiut University

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).

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Study Start: 2025-04-20
• Primary Completion: 2027-04-20
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 49

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,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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.

Secondary Outcome Measures

Name	Time	Method
The Modified Mallampati Score (MMS).	At Intubation	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.
The thyromental distance (TMD)	preoperative	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.
The upper lip bite test (ULBT)	Preoperative	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.

Trial Locations

Locations (1)

Assiut university Pediatric hospital; 🇪🇬 Assiut, Assiut Governorate, Egypt