Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery

NCT06667921 | Recruiting

• 1 other identifier: 36265MD172/11/23
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the diagnostic accuracy of ultrasonographic airway examination in predicting difficult laryngoscopy in pediatric patients undergoing elective surgery.

Conditions

Ultrasonographic; Airway; Difficult Laryngoscopy; Pediatric; Elective Surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of ultrasound measurement of hyomental distance ratio (HMDR)

  Accuracy of ultrasound measurement of hyomental distance ratio (HMDR) in predicting difficult laryngoscopy will be recorded

  10 minutes till placement of endotracheal tube

Secondary Outcomes (2)

• Accuracy of ultrasound measurement of distance from skin to epiglottis (DSE)

  10 minutes till placement of endotracheal tube

• Correlation between the pre-anaesthetic ultrasonographic airway assessment, hyomental distance ratio (HMDR) and distance from skin to epiglottis (DSE)

  10 minutes till placement of endotracheal tube

Study Arms (1)

Ultrasonographic group

Ultrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE).

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound will be used to measure the hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), (HMDR) and (DSE).

Ultrasonographic group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will be carried out on 308 children of both genders, American Society of Anesthesiology (ASA) physical status I or II, who will be prepared for elective surgery under general anaesthesia with tracheal intubation.

You may qualify if:

• Children aged (2-5) years old.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I or II.
• Undergoing elective surgery under general anaesthesia with endotracheal intubation.

You may not qualify if:

• Maxillofacial trauma
• Large mass.
• Scar under the chin.
• History of neck surgery or congenital anomalies of the head and neck as difficult intubation is expected in these cases.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Mohammed M Abo Farrag, Master

CONTACT

00201010632778; m.farrag1990@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: October 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)