Diagnostic ImagingECHOSINCT03818139
Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates
An observational study of Diagnostic Imaging and Newborn, run by University Hospital, Limoges at 1 site in France.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnostic Imaging, Newborn, Intubation
- What is being tested?
- radiography thorax
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2019to 13 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborns treated with mechanical ventilation and required chest X ray for determining ETT position
Who may be able to join
- 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
Who cannot join
- Congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Diagnostic Imaging, Newborn, Intubation, Ultrasonography
- Being tested
- radiography thorax
- Keywords
- diagnostic imaging, Newborn, Intubation, Ultrasonography methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiography thoraxOther
The ultrasound of the thorax will be performed while waiting for the X-ray thorax
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (3)
time of realization lung US
time of realization lung US
Measured: Day 0
time of realization chest X ray
time of realization chest X ray
Measured: Day 0
variability inter observator
Concordance of thoracic ultrasound results between the operator and the reviewer
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start30 Jan 2019
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818139
- Sponsor's protocol ID
- 87RI18_0022 (ECHOSI)
- Acronym
- ECHOSI
- Status last verified
- Jul 2022
- First submitted
- 23 Jan 2019
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates
- ClinicalTrials.gov ID
- NCT03818139
- Acronym / sponsor ID
- ECHOSI / 87RI18_0022 (ECHOSI)
- Conditions
- Diagnostic Imaging, Newborn, Intubation, Ultrasonography
- Keywords
- diagnostic imaging, Newborn, Intubation, Ultrasonography methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborns treated with mechanical ventilation and required chest X ray for determining ETT position
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiography thoraxThe ultrasound of the thorax will be performed while waiting for the X-ray thorax | Other | – |
Primary outcome
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
3 secondary outcomes
time of realization lung US
Time frame: Day 0
time of realization chest X ray
Time frame: Day 0
variability inter observator
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
Related trials for Diagnostic Imaging
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging and Newborn, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of ETT positioning according to lung ultrasonography with chest X ray results (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.