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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Intubation, Intratracheal Other: lung ultrasound

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.

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patients with malposition of the oesophageal or selective intubation probe [ Time Frame: day of enrollment ]
  2. Number of mobilized intubation probes [ Time Frame: day of enrollment ]
    Due to inefficient ventilation and despite undetected malposition

  3. Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator [ Time Frame: day of enrollment ]
  4. Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator [ Time Frame: day of enrollment ]
  5. Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator [ Time Frame: day of enrollment ]
  6. Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator [ Time Frame: day of enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated and ventilated minors
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

Information from the National Library of Medicine

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


Locations
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France
Intensive Care Unit of Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Julie Starck, MD AP-HP, Necker hospital
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02822846    
Other Study ID Numbers: 2016-04-07
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lung ultrasound
Sliding lung
Probe position