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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06443424
Other study ID # pocus in pediatric airway
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 5, 2024
Est. completion date March 1, 2026

Study information

Verified date June 2024
Source Zagazig University
Contact heba elshair, M.B, B.Ch
Phone +201064157744
Email hebaelshair558@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 101
Est. completion date March 1, 2026
Est. primary completion date June 5, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 4 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Airway Complication of Anesthesia

Intervention

Device:
ultrasound device
usage of ultrasound device in pediatric airway asessment

Locations

Country Name City State
Egypt Faculty of Medicine Zagazig Sharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Brambrink AM, Braun U. Airway management in infants and children. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):675-97. doi: 10.1016/j.bpa.2005.07.002. — View Citation

Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28. — View Citation

Lee SU, Jung JY, Kim DK, Kwak YH, Kwon H, Cho JH, Park JW, Choi YJ. New decision formulas for predicting endotracheal tube depth in children: analysis of neck CT images. Emerg Med J. 2018 May;35(5):303-308. doi: 10.1136/emermed-2017-206795. Epub 2018 Feb 6. — View Citation

Lin J, Bellinger R, Shedd A, Wolfshohl J, Walker J, Healy J, Taylor J, Chao K, Yen YH, Tzeng CT, Chou EH. Point-of-Care Ultrasound in Airway Evaluation and Management: A Comprehensive Review. Diagnostics (Basel). 2023 Apr 25;13(9):1541. doi: 10.3390/diagnostics13091541. — View Citation

Litman RS, McDonough JM, Marcus CL, Schwartz AR, Ward DS. Upper airway collapsibility in anesthetized children. Anesth Analg. 2006 Mar;102(3):750-4. doi: 10.1213/01.ane.0000197695.24281.df. — View Citation

Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14. — View 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. — View Citation

Santillanes G, Gausche-Hill M. Pediatric airway management. Emerg Med Clin North Am. 2008 Nov;26(4):961-75, ix. doi: 10.1016/j.emc.2008.08.004. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Estimation of tube size using point of care ultrasound compared to age formula in pediatric population estimate tubal size by ultasound parameters;distance from the skin to the anterior part of the trachea at the hyoid level (ANS-hyoid), The Anterior Neck Soft Tissue Thickness at the level of the vocal Cords. (ANS-VC), The pre - epiglottic space (Pre-E ), the distance from the epiglottis to the mid - point of the distance between the vocal cords (E-VC) , The subglottic transverse diameter and compare with age formula in pediatric pre induction
Secondary Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway determine the accuracy of point of care ultrasound in assessing challenging pediatric airway in correlation to Cormack Lehane grading in pediatric patients pre induction
Secondary Record any obstacles that may interfere with the ultrasound ? To record any obstacles that may interfere with the ultrasound assessment such as: acoustic, anatomic , optical illusion artifact. during opeartion
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