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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361929
Other study ID # MS-259-2019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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