Child, Intubation Complication, Ultrasonography
Conditions
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.
Interventions
BEHAVIORALUltrasound-guided determination of cuffless RAE tube depth
1. Measurement of Carina-T2 mid-vertebra length from preoperative Cheat PA 2. Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field. 3. Withdrawal of the cuffless RAE tube using the Carina-T2 mid-vertebra length for optimal positioning
BEHAVIORALAuscultation-guided determination of cuffless RAE tube depth
1. Measurement of Carina-T2 mid-vertebra length from preoperative Cheat PA 2. Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field 3. Withdrawal of the cuffless RAE tube using the Carina-T2 mid-vertebra length for optimal positioning
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed