Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates (ECHOSI)

July 22, 2022 updated by: University Hospital, Limoges

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: radiography thorax

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Limoges, France, 87042
    - University Hospital, Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborns treated with mechanical ventilation and required chest X ray for determining ETT position

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of ETT positioning according to lung ultrasonography with chest X ray results Time Frame: Day 0	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of realization lung US Time Frame: Day 0	time of realization lung US	Day 0
time of realization chest X ray Time Frame: Day 0	time of realization chest X ray	Day 0
variability inter observator Time Frame: Day 0	Concordance of thoracic ultrasound results between the operator and the reviewer	Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

June 13, 2022

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria