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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-25

Study Completion Date

2022-12-01

Brief Summary

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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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Detailed Description

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* 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.

Conditions

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Airway Complication of Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube (Flexicare-UK) ) with its outer diameter determined by ultrasonography.

cuffed endotracheal tube

Intervention Type DEVICE

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

Group II

Patients will be anesthetized using uncuffed endotracheal tube (Flexicare-UK) with its outer diameter determined by ultrasonography.

Uncuffed endotracheal tube

Intervention Type DEVICE

Patients will be anesthetized using uncuffed endotracheal tube

Interventions

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cuffed endotracheal tube

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

Intervention Type DEVICE

Uncuffed endotracheal tube

Patients will be anesthetized using uncuffed endotracheal tube

Intervention Type DEVICE

Other Intervention Names

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C ETT ETT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No