Clinical trial NCT06667921: Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery
Official title: The Diagnostic Efficacy of Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery; A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasonographic
Airway
Difficult Laryngoscopy
Pediatric
Elective Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 308
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: A difficult airway in a paediatric patient can be a stressful situation for anaesthesiologists as the most common causes of anaesthesia-related deaths were the result of difficult intubation, which is a more common problem in children than in adults.

Ultrasonography is a valuable, promising tool for preoperative airway evaluation through identifying important son anatomy of the upper airway, such as epiglottis, thyroid cartilage, and vocal cords.

Many studies have shown that some ultrasonic parameters can predict difficult airways in adults, such as tongue thickness, hyomental distance in the extended position (HMDE), distance from skin to epiglottis (DSE), tongue volume, midsagittal tongue cross-sectional area (TCSA), and tongue width. However, whether these parameters can be used to predict difficult laryngoscopy in children is unclear and needs extensive studies

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accuracy of ultrasound measurement of hyomental distance ratio (HMDR)
timeFrame: 10 minutes till placement of endotracheal tube
Secondary outcomes:
measure: Accuracy of ultrasound measurement of distance from skin to epiglottis (DSE)
timeFrame: 10 minutes till placement of endotracheal tube
measure: Correlation between the pre-anaesthetic ultrasonographic airway assessment, hyomental distance ratio (HMDR) and distance from skin to epiglottis (DSE)
timeFrame: 10 minutes till placement of endotracheal tube
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: