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

Intubation, Intratracheal Clinical Trial

— ECOVERA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822846
• Other study ID #: 2016-04-07
• Status: Completed
• Start date: November 19, 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Other:
• lung ultrasound

Locations

Country	Name	City	State
France	Intensive Care Unit of Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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