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Clinical Trials/NCT03560895
NCT03560895
Completed
Not Applicable

Ultrasonographic Prediction of Actual Tube Size and Performance Characteristics of Cuffed Vs Un-Cuffed Endotracheal Tubes in Pediatric Surgical Patients.

Assiut University1 site in 1 country100 target enrollmentJune 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Complication of Anesthesia
Sponsor
Assiut University
Enrollment
100
Locations
1
Primary Endpoint
The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study will be to test the accuracy of Sonography in determining the endotracheal tube size in pediatric patients whether cuffed or un-cuffed.

Detailed Description

* Children's tracheas have traditionally been intubated with un-cuffed tracheal tubes (TT) due to differences between adult and pediatric sub-glottic anatomy and fears that cuffs may lead to mucosal damage and subglottic stenosis. Despite this, cuffed TTs are increasingly used in pediatric anesthesia. Over the last 20 years, evidence suggests that cuffed TT may have advantages over un-cuffed, and are associated with at least similar, if not superior, airway outcomes when compared with un-cuffed TT in children. * Formulas based on age and height often fail to reliably predict the proper endotracheal tube (ETT) size in pediatric patients. Visualization of the pediatric subglottic airway diameter by ultrasonography (USG) can enable a practitioner to better predict ETT size, preventing unnecessary tube changes and airway trauma. Also, Visualization of the transvers diameter of epiphyseal end of distal radius by ultrasonography (USG) has been recently investigated and can enable a practitioner to better predict ETT size. Recent reports suggest that the diameter of the subglottic upper airway can be determined by ultrasonography in healthy young adults and pediatric patients . However, the extent to which ultrasonography by these two measurements can predict optimal ETT size in pediatric patients remains under investigation.

Registry
clinicaltrials.gov
Start Date
June 25, 2018
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hala Saad Abdel-Ghaffar

Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Assiut University

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.

Outcomes

Primary Outcomes

The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

Time Frame: AT induction of anesthesia

The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

Study Sites (1)

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