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CompletedNCT02822846ECOVERAUpdated Sep 12, 2025

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

An observational study in Intubation, Intratracheal, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
79
Ages
1 Day to 18 Years
Sex
All
01

Study summary

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
Read the 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.

02

Conditions studied

  • Intubation, Intratracheal

Keywords

  • Lung ultrasound
  • Sliding lung
  • Probe position
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intubated and ventilated minors

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

Exclusion Criteria:

  • Children too unstable : decompensated shock
  • Spontaneous pneumothorax
  • Heart massage ongoing
  • Chest trauma
  • Faulty position of the probe intubation
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
79 participants (actual)
Patient registry
No

Interventions

  • Otherlung ultrasound
06

What researchers measure

Primary outcomes

  1. Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography

    correct position is defined by : * visualization of the probe intubation extremity in endotracheal * visualization of bilateral lung sliding

    Time frame: day of enrollment

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

    Due to inefficient ventilation and despite undetected malposition

    Time frame: day of enrollment

  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

07

Study locations

1 site
  • Intensive Care Unit of Necker Hospital
    Paris, Paris 75015, France
08

References and documents

Publications

  • Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016. PubMed 10195521 ↗
  • Harris EA, Arheart KL, Penning DH. Endotracheal tube malposition within the pediatric population: a common event despite clinical evidence of correct placement. Can J Anaesth. 2008 Oct;55(10):685-90. doi: 10.1007/BF03017744. PubMed 18835966 ↗
  • Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1. PubMed 23211476 ↗
  • Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21. PubMed 25711517 ↗
  • Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8. PubMed 22092123 ↗
  • American College of Emergency Physicians. Clinical Policies Committee. Verification of endotracheal tube placement. Ann Emerg Med. 2002 Nov;40(5):551-2. No abstract available. PubMed 12425285 ↗
  • Guerder M, Maurin O, Merckx A, Foissac F, Oualha M, Renolleau S, Vedrenne-Cloquet M. Diagnostic value of pleural ultrasound to refine endotracheal tube placement in pediatric intensive care unit. Arch Pediatr. 2021 Nov;28(8):712-717. doi: 10.1016/j.arcped.2021.09.006. Epub 2021 Oct 6. PubMed 34625381 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02822846
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Jul 4, 2016
Start date
Nov 19, 2016
Primary completion
Nov 2018
Completion
Nov 2018
Last update
Sep 12, 2025

Study contacts

Julie Starck, MD
principal investigator · AP-HP, Necker hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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