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Completed

NCT Number: NCT02822846

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

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

Completed

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit of Necker Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung ultrasound

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of patients with malposition of the oesophageal or selective intubation probe

    Time frame: day of enrollment

  2. Number of mobilized intubation probes

    Time frame: day of enrollment

    Due to inefficient ventilation and despite undetected malposition

  3. Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator

    Time frame: day of enrollment

  4. Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator

    Time frame: day of enrollment

  5. Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator

    Time frame: day of enrollment

  6. Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator

    Time frame: day of enrollment

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ECOVERA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 4, 2016
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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