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Not Yet RecruitingNCT06892405

Airway US in Predicting Difficult Pediatric Laryngoscopy

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
49 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICESonoSite™ S Series ultrasoundUS 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.

Timeline

Start date
2025-04-20
Primary completion
2027-04-20
Completion
2027-05-01
First posted
2025-03-24
Last updated
2025-03-24

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06892405. Inclusion in this directory is not an endorsement.