NCT06443424

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

May 30, 2024

Last Update Submit

June 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway

    pre induction

  • Record any obstacles that may interfere with the ultrasound

    during opeartion

Interventions

usage of ultrasound device in pediatric airway asessment

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 19059095BACKGROUND
  • 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.

    PMID: 16408541BACKGROUND
  • 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.

    PMID: 16492823BACKGROUND
  • 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.

    PMID: 31073483BACKGROUND
  • 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.

    PMID: 21401798BACKGROUND
  • 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.

    PMID: 29437848BACKGROUND
  • 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.

    PMID: 37174933BACKGROUND
  • 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.

    PMID: 36960139BACKGROUND
  • 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.

    PMID: 37491186BACKGROUND
  • 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.

    PMID: 28658880BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • heba elshair, M.B, B.Ch

    Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

heba elshair, M.B, B.Ch

CONTACT

alshaimaa kamel, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of Anesthesia, Intensive care and PaiN Managment

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

July 25, 2024

Primary Completion

January 5, 2025

Study Completion

October 1, 2025

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations