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

NCT ID: NCT02822846

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-19

Study Completion Date

2018-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Intubation, Intratracheal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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lung ultrasound

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Starck, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Necker hospital

Locations

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Intensive Care Unit of Necker Hospital

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 10195521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18835966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23211476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25711517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22092123 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12425285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34625381 (View on PubMed)

Other Identifiers

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2016-04-07

Identifier Type: -

Identifier Source: org_study_id

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