Pediatric Difficult Airway Prediction Using Ultrasonography

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04361929
• Collaborator: (none)
• Enrollment: 584
• Location: 1
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 23.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Difficult Intubation; Difficult Mask Ventilation	Device: Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 584 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pediatric Difficult Airway Prediction Using Ultrasonography
• Actual Study Start Date: Apr 26, 2020
• Actual Primary Completion Date: May 10, 2022
• Actual Study Completion Date: May 15, 2022

Outcome Measures

Primary Outcome Measures

1. The sensitivity of DS-HB to predict difficult laryngoscopy [30 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al Ainy	Cairo		Egypt	11559

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heba Nassar,MD, Associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04361929
• Other Study ID Numbers: MS-259-2019
• First Posted: Apr 24, 2020
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heba Nassar,MD, Associate professor, Cairo University: Difficult airway; pediatric; Airway ultrasound

Study Results

No Results Posted as of Jul 20, 2022