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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03560895

Acronym

USETT

Enrollment

100

Registered

2018-06-18

Start date

2018-06-25

Completion date

2022-12-01

Last updated

2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia

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.

Interventions

DEVICEcuffed endotracheal tube

Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube

DEVICEUncuffed endotracheal tube

Patients will be anesthetized using uncuffed endotracheal tube

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026