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Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department (POCUYTO)

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ClinicalTrials.gov Identifier: NCT03846934
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for pleural liquid (PL) diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.


Condition or disease Intervention/treatment
Pleural Effusion Ultrasonography Thoracic Acute Respiratory Failure Emergencies Device: Ultrasonography thoracic

Detailed Description:

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for PL diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.


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Study Type : Observational
Estimated Enrollment : 223 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


Group/Cohort Intervention/treatment
Ultrasonography thoracic
Ultrasonography thoracic
Device: Ultrasonography thoracic
Thoracic ultrasonography will be performed as soon as possible after admission to the ED, without delaying the start of treatment and in addition to routine thoracic radiography.




Primary Outcome Measures :
  1. Clinically relevant Pleural Effusions (PE) [ Time Frame: Day 1 ]
    Number and proportion of ARF patients for whom the thoracic ultrasonography realized in ED shows a clinically relevant PE (> 2cm)


Secondary Outcome Measures :
  1. Inter-pleural distance to the inspiration [ Time Frame: Day 1 ]
    Measuring of the inter-pleural distance to the inspiration (patient in spontaneous ventilation) in cross-section

  2. Additional diagnostic elements [ Time Frame: Day 1 ]

    Number and proportion of patients for whom the thoracic ultrasound provides additional diagnostic evidence in comparison to clinical examination and the standard thoracic radiography in frontal bed, ie:

    Presence of an PE Abundant PE> 800 mL Or any other pleuro-parenchymal abnormalities identified by ultrasound (pneumothorax, condensation of lung parenchyma ...) and not on standard radiography




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient admitted to ED and presenting with clinical signs of ARF
Criteria

Inclusion Criteria:

  • Patient admitted to the ED
  • AND Age >= 18 years
  • AND affiliated or beneficiary to a social security scheme
  • AND with clinical signs of ARF:

    • Cyanosis, mottling, encephalopathy
    • Respiratory exhaustion (thoraco abdominal balancing, accessory muscle play)
    • Pulse oxygen saturation (SpO2) <92% in the air
  • AND/OR showing biological signs of ARF:

    • Arterial oxygen pressure (PaO2) <60 mmHg
    • Or PaO2 / fraction of inspired oxygen (FiO2) ratio <400.

Exclusion Criteria:

  • Patient moribund or for whom a limitation of the care is envisaged
  • Pregnant woman
  • Absence of exploitable ultrasound image for any reason.

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): NCT03846934


Contacts
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Contact: Thomas LAFON, MD 555055555 ext +33 thomas.lafon@chu-limoges.fr
Contact: Clément RAYNAUD, MD 555055555 ext +33 clement.raynaud@chu-limoges.fr

Locations
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France
CHU de Limoges Not yet recruiting
Limoges, France, 87042
Contact: Thomas LAFON, MD       thomas.lafin@chu-limoges.fr   
Principal Investigator: Thomas LAFON, MD         
Sub-Investigator: Pauline FEYDEAU         
Sub-Investigator: Clément RAYNAUD         
Sub-Investigator: Arthur BAISSE         
Sub-Investigator: Vincent BIGRAT         
Sub-Investigator: Thomas BRIANCHON         
Sub-Investigator: Emilie VALANTIN         
Sub-Investigator: Marine GOUDELIN         
Sub-Investigator: Anne-Laure FEDOU         
Sponsors and Collaborators
University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03846934     History of Changes
Other Study ID Numbers: 87RI18_032 (POCUYTO)
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Limoges:
Pleural Effusion
Ultrasonography
Thoracic
Acute Respiratory Failure
Emergencies

Additional relevant MeSH terms:
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Emergencies
Respiratory Insufficiency
Pleural Effusion
Respiratory Distress Syndrome, Adult
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Pleural Diseases
Lung Diseases