Ultrasound vs. Auscultation for Optimal Depth of the Cuffless RAE Tube

Not Applicable

Withdrawn

• Conditions: Intubation Complication; Child; Ultrasonography

• Registration Number: NCT04246411
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aim of this study is to compare the ultrasound-guidance versus auscultation to confirm optimal insertion depth of the cuffless oral Ring-Adair-Elwyn (RAE) endotracheal tube in pediatric patients undergoing general anesthesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Study Start: 2020-02-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children age under 7 years
• Undergoing general anesthesia
• Endobronchial intubation with cuffless oral RAE tube

Exclusion Criteria

• Pulmonary disease
• Active upper respiratory tract infection
• History of upper or lower respiratory tract infection within 2 weeks
• Emergent operation
• Unstable vital sign

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of optimal location of the cuffless Oral RAE tube (%)	during operation (until endotracheal extubation) up to 18 hour after induction	The distance between the tip of cuffless RAE tube and right pulmonary artery is within the -5mm \~ +5mm value of the distance between the T2 mid-vertebra and carina (optimal depth)

Secondary Outcome Measures

Name	Time	Method
M-distance (between the carina and the T2 mid-vertebra)	during operation up to 18 hour after induction	The distance between T2 mid-vertebra and the carina)
Distance between the optimal depth and the relocated depth	during operation up to 18 hour after induction	Distance between the optimal depth and the relocated depth
Subglottic diameter at the cricoid cartilage level	during operation	Subglottic diameter at the cricoid cartilage level using neck US
ID and OD of optimal cuffless oral RAE tube	during operation up to 18 hour after induction	Internal and external diameter of optimal cuffless oral RAE tube
Time from intubation to confirming the tube depth	during operation up to 18 hour after induction	Time from intubation to confirming the tube depth (seconds)
Distance between the optimal depth and the manufacturer's recommended depth	during operation up to 18 hour after induction	Distance between the optimal depth and the manufacturer's recommended depth
Airway leakage pressure	during operation up to 18 hour after induction	Airway leakage pressure measured by manual ventilation with APL(Adjustable pressure-limiting) valve
Incidence of the intraoperative airway-related events	during operation up to 18 hour after induction	accidental extubation, endobronchial intubation, desaturation (SpO2 \< 95%), etc
Incidence of the airway-related symptoms after extubation	up to 18 hour after induction	hoarseness, stridor, laryngospasm, chest retraction, etc

Trial Locations

Locations (1)

Hee-Soo Kim; 🇰🇷 Seoul, Soul-t'ukpyolsi, Korea, Republic of