Clinical trial NCT06443424: Assessment of Pediatric Challenging Airway
Official title: Preoperative Assessment of Pediatric Challenging Airway and Endotracheal Tube Sizing Using Point-of-Care Ultrasound Versus Traditional Methods in Elective Surgeries
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Airway Complication of Anesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-06-05
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric population

Brief summary: The goal of these Observational study is to learn about pediatric airway the main question to answer is:

1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and the endotracheal tube sizing more than traditional methods.


Eligibility criteria: Inclusion Criteria:

* Patient's parents' consent.
* Age:from one to 4 years old.
* Both sexes (male and female).
* BMI with in (5-85%) of body mass index of the child birth of same age and sex.
* Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
* Type of operation: elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Pre-existing airway malformations or pathology like facial or cervical fracture
* Deformity of the airway anatomy \[by masses or tumors\].
* Pathology of the airway \[edema, burn and arthritis\].
* Anticipated difficult airway

Primary outcomes:
measure: Estimation of tube size using point of care ultrasound compared to age formula in pediatric population
timeFrame: pre induction
Secondary outcomes:
measure: Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway
timeFrame: pre induction
measure: Record any obstacles that may interfere with the ultrasound
timeFrame: during opeartion
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig university
name: heba elshair, M.B, B.Ch
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
citation: Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023 Jul 25;23(1):78. doi: 10.1186/s12873-023-00852-4.
citation: Sutagatti JG, Raja R, Kurdi MS. Ultrasonographic Estimation of Endotracheal Tube Size in Paediatric Patients and its Comparison with Physical Indices Based Formulae: A Prospective Study. J Clin Diagn Res. 2017 May;11(5):UC05-UC08. doi: 10.7860/JCDR/2017/25905.9838. Epub 2017 May 1.