ECHOSI: Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

• Sponsor: University Hospital, Limoges (Other)
• Overall Status: Completed
• CT.gov ID: NCT03818139
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Actual Duration (Months): 40.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Imaging; Newborn; Intubation; Ultrasonography	Other: radiography thorax

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates
• Actual Study Start Date: Jan 30, 2019
• Actual Primary Completion Date: Jun 13, 2022
• Actual Study Completion Date: Jun 13, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. time of realization lung US [Day 0]

   time of realization lung US

2. time of realization chest X ray [Day 0]

   time of realization chest X ray

3. variability inter observator [Day 0]

   Concordance of thoracic ultrasound results between the operator and the reviewer

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Limoges	Limoges		France	87042

Sponsors and Collaborators

• University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Limoges
• ClinicalTrials.gov Identifier: NCT03818139
• Other Study ID Numbers: 87RI18_0022 (ECHOSI)
• First Posted: Jan 28, 2019
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Limoges: diagnostic imaging, Newborn, Intubation, Ultrasonography methods

Study Results

No Results Posted as of Jul 25, 2022