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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intubation Complication, Child, Ultrasonography

Intervention / Treatment
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* Behavioral: Ultrasound-guided determination of cuffless RAE tube depth
* Behavioral: Auscultation-guided determination of cuffless RAE tube depth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound<br>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<br>* 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<br>|
| Placebo Comparator: Auscultation<br>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<br>* 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<br>|

What is the study measuring?
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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 |