Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-28 @ 9:11 PM
Study NCT ID:
NCT03560895
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Ultrasonographic Prediction of Actual Tube Size and Performance Characteristics of Cuffed Vs Un-Cuffed Endotracheal Tubes in Pediatric Surgical Patients.
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USETT
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: