Clinical trial NCT04246411: Ultrasound vs. Auscultation for Optimal Depth of the Cuffless RAE Tube
Official title: Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intubation Complication
Child
Ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 0
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of optimal location of the cuffless Oral RAE tube (%)
timeFrame: during operation (until endotracheal extubation) up to 18 hour after induction
Secondary outcomes:
measure: M-distance (between the carina and the T2 mid-vertebra)
timeFrame: during operation up to 18 hour after induction
measure: Distance between the optimal depth and the relocated depth
timeFrame: during operation up to 18 hour after induction
measure: Subglottic diameter at the cricoid cartilage level
timeFrame: during operation
measure: ID and OD of optimal cuffless oral RAE tube
timeFrame: during operation up to 18 hour after induction
measure: Time from intubation to confirming the tube depth
timeFrame: during operation up to 18 hour after induction
measure: Distance between the optimal depth and the manufacturer's recommended depth
timeFrame: during operation up to 18 hour after induction
measure: Airway leakage pressure
timeFrame: during operation up to 18 hour after induction
measure: Incidence of the intraoperative airway-related events
timeFrame: during operation up to 18 hour after induction
measure: Incidence of the airway-related symptoms after extubation
timeFrame: up to 18 hour after induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
Study officials:
affiliation: Professor, Seoul National University Hospital
name: Hee-Soo Kim, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.