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Completed

NCT Number: NCT03560895

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

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.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric hospital, faculty of medicine, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cuffed endotracheal tube

Device

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

Other names: C ETT

Uncuffed endotracheal tube

Device

Patients will be anesthetized using uncuffed endotracheal tube

Other names: ETT

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: USETT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2018
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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