Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

Pediatric General Anesthesia With Endotracheal Tube Clinical Trial

Official title:

Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321956
• Other study ID #: RAti-001
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: June 4, 2017
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

Description:

This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• Age 1-6 Years

• ASA class 1-2

• Elective Surgery

• GA with oral uncuff endotracheal tube

Exclusion Criteria:

• Potential difficult air way from history and physical exam

• Allergy ti ultrasound gel

• neck mass

• unstable vital sign

Related Conditions & MeSH terms

• Pediatric General Anesthesia With Endotracheal Tube

Intervention

Diagnostic Test:
• Ultrasound
Using ultrasound to determine the size of endotracheal tube

Locations

Country	Name	City	State
Thailand	Raviwon Atisook	Bangkok	Bangkoknoi

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proper size of endotracheal tube	Clinically fit of endotracheal tube with leak at 20-25 cmH2O	1 year
Secondary	Correlation of subglottic diameter and proper size endotracheal tube	Correlation of subglottic diameter measured by ultrasound and proper size endotracheal tube determined by clinically fit.	1 year