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

Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Child; Ultrasonography; Intubation Complication
• Intervention / Treatment: Behavioral: Ultrasound-guided determination of cuffless RAE tube depth; Behavioral: Auscultation-guided determination of cuffless RAE tube depth

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soul-t'ukpyolsi
    • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
      • Hee-Soo Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound; Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field	Behavioral: Ultrasound-guided determination of cuffless RAE tube depth; Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA; Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field.; Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning
Placebo Comparator: Auscultation; Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field	Behavioral: Auscultation-guided determination of cuffless RAE tube depth; Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA; Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field; Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of optimal location of the cuffless Oral RAE tube (%)	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)	during operation (until endotracheal extubation) up to 18 hour after induction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Soo Kim, MD.PhD, Professor, Seoul National University Hospital

Publications and helpful links

General Publications

• Altun D, Orhan-Sungur M, Ali A, Ozkan-Seyhan T, Sivrikoz N, Camci E. The role of ultrasound in appropriate endotracheal tube size selection in pediatric patients. Paediatr Anaesth. 2017 Oct;27(10):1015-1020. doi: 10.1111/pan.13220. Epub 2017 Aug 28.
• Ahn JH, Kwon E, Lee SY, Hahm TS, Jeong JS. Ultrasound-guided lung sliding sign to confirm optimal depth of tracheal tube insertion in young children. Br J Anaesth. 2019 Sep;123(3):309-315. doi: 10.1016/j.bja.2019.03.020. Epub 2019 Apr 12.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: US-RAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No