Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography (ECOVERA)

September 8, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe

The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

  • sonography
  • chest radiography

A correct position of the intubation probe will be considered if there is :

  • Highlighting of the extremity of the intubation probe in endo tracheal
  • Highlighting bilateral lung sliding

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc… It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.

The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.

After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.

Study Type

Observational

Enrollment (Actual)

79

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
    • Paris
      • Paris, Paris, France, 75015
        • Intensive Care Unit of Necker Hospital

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

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Intubated and ventilated minors

Description

Inclusion Criteria:

  • Patient less than 18 years old
  • Patient intubated and ventilated
  • intubation probe considered in place on auscultation
  • SpO2> 92%
  • Affiliate or entitled to a social security scheme
  • No opposition of any of the parents.

Exclusion Criteria:

  • Children too unstable : decompensated shock
  • Spontaneous pneumothorax
  • Heart massage ongoing
  • Chest trauma
  • Faulty position of the probe intubation

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography
Time Frame: day of enrollment

correct position is defined by :

  • visualization of the probe intubation extremity in endotracheal
  • visualization of bilateral lung sliding
day of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with malposition of the oesophageal or selective intubation probe
Time Frame: day of enrollment
day of enrollment
Number of mobilized intubation probes
Time Frame: day of enrollment
Due to inefficient ventilation and despite undetected malposition
day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator
Time Frame: day of enrollment
day of enrollment
Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator
Time Frame: day of enrollment
day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator
Time Frame: day of enrollment
day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator
Time Frame: day of enrollment
day of enrollment

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Investigators

  • Principal Investigator: Julie Starck, MD, AP-HP, Necker hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 19, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimated)

July 4, 2016

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-04-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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