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

NCT ID: NCT04246411

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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Intubation Complication Child Ultrasonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasound

Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field

Group Type ACTIVE_COMPARATOR

Ultrasound-guided determination of cuffless RAE tube depth

Intervention Type BEHAVIORAL

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

Auscultation

Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field

Group Type PLACEBO_COMPARATOR

Auscultation-guided determination of cuffless RAE tube depth

Intervention Type BEHAVIORAL

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

Interventions

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Ultrasound-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

Intervention Type BEHAVIORAL

Auscultation-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

Intervention Type BEHAVIORAL

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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Soo Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Seoul National University Hospital

Locations

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Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 28846176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30987765 (View on PubMed)

Other Identifiers

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US-RAE

Identifier Type: -

Identifier Source: org_study_id

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