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

NCT02822846 | Completed

• 1 other identifier: 2016-04-07
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intubation, Intratracheal

Keywords

Lung ultrasound; Sliding lung; Probe position

Outcome Measures

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

  day of enrollment

Secondary Outcomes (6)

• Number of patients with malposition of the oesophageal or selective intubation probe

  day of enrollment

• Number of mobilized intubation probes

  day of enrollment

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

  day of enrollment

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

  day of enrollment

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

  day of enrollment

Interventions

lung ultrasound OTHER

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Intubated and ventilated minors

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Intensive Care Unit of Necker Hospital

Paris, Paris, 75015, France

Location

Related Publications (7)

• 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.

  PMID: 10195521 BACKGROUND

• 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.

  PMID: 18835966 BACKGROUND

• 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.

  PMID: 23211476 BACKGROUND

• 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.

  PMID: 25711517 BACKGROUND

• 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.

  PMID: 22092123 BACKGROUND

• 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.

  PMID: 12425285 BACKGROUND

• 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.

  PMID: 34625381 BACKGROUND

Study Officials

• Julie Starck, MD

  AP-HP, Necker hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: November 19, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)