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NCT03818139 Clinical Trial

Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Ultrasonography Clinical Trial

— ECHOSI  

Official title:
Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03818139
Other study ID # 87RI18_0022 (ECHOSI)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date June 13, 2022

Study information
Verified date July 2022
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube (ETT) position in adults and children but has been less studied in neonates. The aim of this study is to evaluate the performance of lung US in determining correct ETT position in neonates, in comparison with X Ray

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date June 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Newborns - treated with mechanical ventilation - and required chest X ray for determining ETT position - hospitalised in neonatal intensive Care unit , Limoges, France - signed parental inform consent Exclusion Criteria: - Congenital heart disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• radiography thorax
The ultrasound of the thorax will be performed while waiting for the X-ray thorax

Locations
Country Name City State
France University Hospital, Limoges Limoges

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concordance of ETT positioning according to lung ultrasonography with chest X ray results X Ray correct ETT position : ETT's tip will be correctly positioned if located between the upper edge of the first thoracic vertebra and the lower edge of the second thoracic vertebra.
Ultrasound correct ETT position : ETT'S tip will be correctly positioned if the distance between ETT's tip and the junction of the brachycephalic artery with aortic arch will be measured between 0.8 and 1.5 centimeter		 Day 0
Secondary time of realization lung US time of realization lung US Day 0
Secondary time of realization chest X ray time of realization chest X ray Day 0
Secondary variability inter observator Concordance of thoracic ultrasound results between the operator and the reviewer Day 0
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