Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Completed

• Conditions: Intubation; Diagnostic Imaging; Newborn; Ultrasonography

• Registration Number: NCT03818139
• Lead Sponsor: University Hospital, Limoges

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-28
• Study Start: 2019-01-30
• Primary Completion: 2022-06-13
• Study Completion: 2022-06-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance of ETT positioning according to lung ultrasonography with chest X ray results	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

Secondary Outcome Measures

Name	Time	Method
variability inter observator	Day 0	Concordance of thoracic ultrasound results between the operator and the reviewer
time of realization lung US	Day 0	time of realization lung US
time of realization chest X ray	Day 0	time of realization chest X ray

Trial Locations

Locations (1)

University Hospital, Limoges; 🇫🇷 Limoges, France