Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-09 @ 9:21 AM
Study NCT ID:
NCT03846934
Status:
TERMINATED
Last Update Posted:
2021-10-07
First Post:
2019-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically relevant Pleural Effusions (PE)', 'timeFrame': 'Day 1', 'description': 'Number and proportion of ARF patients for whom the thoracic ultrasonography realized in ED shows a clinically relevant PE (\\> 2cm)'}], 'secondaryOutcomes': [{'measure': 'Inter-pleural distance to the inspiration', 'timeFrame': 'Day 1', 'description': 'Measuring of the inter-pleural distance to the inspiration (patient in spontaneous ventilation) in cross-section'}, {'measure': 'Additional diagnostic elements', 'timeFrame': 'Day 1', 'description': '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:\n\nPresence 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleural Effusion', 'Ultrasonography', 'Thoracic', 'Acute Respiratory Failure', 'Emergencies'], 'conditions': ['Pleural Effusion', 'Ultrasonography', 'Thoracic', 'Acute Respiratory Failure', 'Emergencies']}, 'descriptionModule': {'briefSummary': '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.\n\nThus, 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.', 'detailedDescription': '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.\n\nThus, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted to ED and presenting with clinical signs of ARF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted to the ED\n* AND Age \\>= 18 years\n* AND affiliated or beneficiary to a social security scheme\n* AND with clinical signs of ARF:\n\n * Cyanosis, mottling, encephalopathy\n * Respiratory exhaustion (thoraco abdominal balancing, accessory muscle play)\n * Pulse oxygen saturation (SpO2) \\<92% in the air\n* AND/OR showing biological signs of ARF:\n\n * Arterial oxygen pressure (PaO2) \\<60 mmHg\n * Or PaO2 / fraction of inspired oxygen (FiO2) ratio \\<400.\n\nExclusion Criteria:\n\n* Patient moribund or for whom a limitation of the care is envisaged\n* Pregnant woman\n* Absence of exploitable ultrasound image for any reason.'}, 'identificationModule': {'nctId': 'NCT03846934', 'acronym': 'POCUYTO', 'briefTitle': 'Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department', 'orgStudyIdInfo': {'id': '87RI18_032 (POCUYTO)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasonography thoracic', 'description': 'Ultrasonography thoracic', 'interventionNames': ['Device: Ultrasonography thoracic']}], 'interventions': [{'name': 'Ultrasonography thoracic', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Ultrasonography thoracic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}