Assessment of Pediatric Challenging Airway

June 27, 2024 updated by: Heba Helmy Elshair, Zagazig University

Preoperative Assessment of Pediatric Challenging Airway and Endotracheal Tube Sizing Using Point-of-Care Ultrasound Versus Traditional Methods in Elective Surgeries

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pediatric population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of tube size using point of care ultrasound compared to age formula in pediatric population
Time Frame: pre induction
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway
Time Frame: pre induction
determine the accuracy of point of care ultrasound in assessing challenging pediatric airway in correlation to Cormack Lehane grading in pediatric patients
pre induction
Record any obstacles that may interfere with the ultrasound
Time Frame: during opeartion
● To record any obstacles that may interfere with the ultrasound assessment such as: acoustic, anatomic , optical illusion artifact.
during opeartion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: heba elshair, M.B, B.Ch, Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

January 5, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • pocus in pediatric airway

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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