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

Completed

• Conditions: Airway Complication of Anesthesia
• Interventions: Device: cuffed endotracheal tube; Device: Uncuffed endotracheal tube

• Registration Number: NCT03560895
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Study Start: 2018-06-25
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-22
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

• Upper airway malformations.
• Upper airway surgery.
• Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
• Anticipated difficult airway.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	cuffed endotracheal tube	Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube (Flexicare-UK) ) with its outer diameter determined by ultrasonography.
Group II	Uncuffed endotracheal tube	Patients will be anesthetized using uncuffed endotracheal tube (Flexicare-UK) with its outer diameter determined by ultrasonography.

Primary Outcome Measures

Name	Time	Method
The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT	AT induction of anesthesia	The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

Trial Locations

Locations (1)

Pediatric hospital, faculty of medicine, Assiut university; 🇪🇬 Assiut, Assiut Governorate, Egypt