Clinical trial NCT06166927: The Use of a US-measured Styloid Process of the Distal Radius EET Diameter for Prediction of ETT Size
Official title: The Correlation Between Ultrasound-measured Styloid Process of the Distal Radius and the Outer Diameter of the Best-fitting Endotracheal Tube in Pediatrics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Airway Management
Keywords: Children, airway, ETT, US, radial diameter
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.

Brief summary: This study will aim to test the accuracy of the ultrasonography measurement of the epiphyseal diameter of the distal radius in the prediction of the size of the cuffed and uncuffed ETT that best fits in children (1-6 years old) in comparison with the traditional age-based formulas.

Detailed description: Various formulas are used to predict the inner diameter (ID) of the ETT tube whether uncuffed or cuffed based on weight, age, height, and finger size. The accuracy of these formulas is questionable. These formulas depend on the child's demographic characteristics assuming that he/she has normal growth and development and cannot be applied to children with altered growth and development. Moreover, these formulas predict the ID of the ETT ignoring the tube thickness and the OD of the selected tube.

ultrasound has recently been identified as an accurate alternative to these formulas. The US-measured epiphyseal diameter of the distal radius is a method that has been recently introduced as a surrogate for the tracheal diameter. The issue is that the size of the airway can be considered a reflection of the body's growth, assuming that the growth rates of the cartilage all over the body are closely related to each other. Therefore, the measurement of the growth of the bony cartilage of the hand can be considered a surrogate marker of the tracheal diameter.9 The extent to which ultrasonography by this method can succeed in predicting the optimal pediatric ETT size remains under investigation.

Eligibility criteria: Inclusion Criteria:

* Weight: 10-30 kg.
* Age: 1-6 years.
* Sex: both males and females.
* ASA physical status: I-II.
* Operation: elective surgery in which airway management with an endotracheal tube is needed.

Exclusion Criteria:

* Upper airway malformations.
* Upper airway surgery.
* Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
* Anticipated difficult airway.

Primary outcomes:
measure: Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT
timeFrame: At induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university Pediatric hospital
state: Assiut Governorate
Study officials:
affiliation: Assiut University
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: