Pediatric Difficult Airway Prediction Using Ultrasonography

NCT04361929 | Completed

• 1 other identifier: MS-259-2019
• Study Type: observational
• Target: 584
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Difficult Intubation; Difficult Mask Ventilation

Keywords

Difficult airway; pediatric; Airway ultrasound

Outcome Measures

Primary Outcomes (1)

• The sensitivity of DS-HB to predict difficult laryngoscopy

  The ability of DS-HB ultrasound measurement to predict difficult airway in pediatrics

  30 minutes

Interventions

Ultrasound DEVICE

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

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A total of 584 consecutive pediatric patients, aged one month-10 years scheduled for elective surgery under general anesthesia will be included in the study.

You may qualify if:

• Gender both males and females
• ASA Class I and II
• Age 1month to 10 years
• Children undergoing elective surgery under general anaesthesia

You may not qualify if:

• congenital upper airway malformation,
• head and neck swellings,
• scars,
• radiation to the neck,
• tracheotomy,
• Neurosurgical or cardiac procedures
• ENT surgeries

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy

Cairo, 11559, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 26, 2020
• Primary Completion: May 10, 2022
• Study Completion: May 15, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

EG (1)