Pediatric Difficult Airway Prediction Using Ultrasonography

Difficult Intubation Clinical Trial

Official title:

Pediatric Difficult Airway Prediction Using Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361929
• Other study ID #: MS-259-2019
• Status: Completed
• Start date: April 26, 2020
• Est. completion date: May 15, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: May 15, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

Inclusion Criteria:

• Gender both males and females

• ASA Class I and II

• Age 1month to 10 years

• Children undergoing elective surgery under general anaesthesia

Exclusion Criteria:

• congenital upper airway malformation,

• head and neck swellings,

• scars,

• radiation to the neck,

• tracheotomy,

• Neurosurgical or cardiac procedures

• ENT surgeries

Related Conditions & MeSH terms

• Difficult Intubation
• Difficult Mask Ventilation

Intervention

Device:
• Ultrasound
The following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V.

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of DS-HB to predict difficult laryngoscopy	The ability of DS-HB ultrasound measurement to predict difficult airway in pediatrics	30 minutes