Clinical trial NCT02822846: Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
Official title: Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation, Intratracheal
Keywords: Lung ultrasound
Sliding lung
Probe position
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 79
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated and ventilated minors

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography
timeFrame: day of enrollment
Secondary outcomes:
measure: Number of patients with malposition of the oesophageal or selective intubation probe
timeFrame: day of enrollment
measure: Number of mobilized intubation probes
timeFrame: day of enrollment
measure: Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator
timeFrame: day of enrollment
measure: Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator
timeFrame: day of enrollment
measure: Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator
timeFrame: day of enrollment
measure: Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator
timeFrame: day of enrollment
Other outcomes:
Locations:
city: Paris
country: France
facility: Intensive Care Unit of Necker Hospital
Study officials:
affiliation: AP-HP, Necker hospital
name: Julie Starck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.2021.09.006. Epub 2021 Oct 6.