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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04246411
• Other study ID #: US-RAE
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Intubation Complication
• Ultrasonography

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul	Soul-t'ukpyolsi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

Altun D, Orhan-Sungur M, Ali A, Özkan-Seyhan T, Sivrikoz N, Çamci 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Subglottic diameter at the cricoid cartilage level	Subglottic diameter at the cricoid cartilage level using neck US	during operation
Secondary	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
Secondary	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
Secondary	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
Secondary	Airway leakage pressure	Airway leakage pressure measured by manual ventilation with APL(Adjustable pressure-limiting) valve	during operation up to 18 hour after induction
Secondary	Incidence of the intraoperative airway-related events	accidental extubation, endobronchial intubation, desaturation (SpO2 < 95%), etc	during operation up to 18 hour after induction
Secondary	Incidence of the airway-related symptoms after extubation	hoarseness, stridor, laryngospasm, chest retraction, etc	up to 18 hour after induction