NCT04246411

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

January 14, 2020

Last Update Submit

October 12, 2020

Conditions

Intubation ComplicationChildUltrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • M-distance (between the carina and the T2 mid-vertebra)

    during operation up to 18 hour after induction

  • Distance between the optimal depth and the relocated depth

    during operation up to 18 hour after induction

  • Subglottic diameter at the cricoid cartilage level

    during operation

  • ID and OD of optimal cuffless oral RAE tube

    during operation up to 18 hour after induction

  • Time from intubation to confirming the tube depth

    during operation up to 18 hour after induction

  • +4 more secondary outcomes

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

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

Auscultation

PLACEBO COMPARATOR

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

Interventions

Ultrasound-guided determination of cuffless RAE tube depthBEHAVIORAL

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

Ultrasound
Auscultation-guided determination of cuffless RAE tube depthBEHAVIORAL

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

Auscultation

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children age under 7 years
  • Undergoing general anesthesia
  • Endobronchial intubation with cuffless oral RAE tube

You may not qualify if:

  • Pulmonary disease
  • Active upper respiratory tract infection
  • History of upper or lower respiratory tract infection within 2 weeks
  • Emergent operation
  • Unstable vital sign

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28846176BACKGROUND

  • 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.

    PMID: 30987765BACKGROUND

Study Officials

  • Hee-Soo Kim, MD.PhD

    Professor, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 29, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)