Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography (ECOVERA)
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|ClinicalTrials.gov Identifier: NCT02822846|
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : January 9, 2020
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 :
- 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
|Condition or disease||Intervention/treatment|
|Intubation, Intratracheal||Other: lung ultrasound|
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.
|Study Type :||Observational|
|Actual Enrollment :||79 participants|
|Official Title:||Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe|
|Actual Study Start Date :||November 19, 2016|
|Actual Primary Completion Date :||November 2018|
|Actual Study Completion Date :||November 2018|
- Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography [ Time Frame: day of enrollment ]
correct position is defined by :
- visualization of the probe intubation extremity in endotracheal
- visualization of bilateral lung sliding
- Number of patients with malposition of the oesophageal or selective intubation probe [ Time Frame: day of enrollment ]
- Number of mobilized intubation probes [ Time Frame: day of enrollment ]Due to inefficient ventilation and despite undetected malposition
- Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator [ Time Frame: day of enrollment ]
- Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator [ Time Frame: day of enrollment ]
- Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator [ Time Frame: day of enrollment ]
- Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator [ Time Frame: day of enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822846
|Intensive Care Unit of Necker Hospital|
|Paris, France, 75015|
|Principal Investigator:||Julie Starck, MD||AP-HP, Necker hospital|