US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.

Airway Complication of Anesthesia Clinical Trial

— USETT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560895
• Other study ID #: 17200201
• Status: Completed
• Start date: June 25, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Device:
• cuffed endotracheal tube
Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube
• Uncuffed endotracheal tube
Patients will be anesthetized using uncuffed endotracheal tube

Locations

Country	Name	City	State
Egypt	Pediatric hospital, faculty of medicine, Assiut university	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT	The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT	AT induction of anesthesia