Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04328220
Status:
UNKNOWN
Last Update Posted:
2020-04-07
First Post:
2020-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in Pediatric Intensive Care Unit (PICU) Compared to Chest X-ray
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2020-03-28', 'studyFirstSubmitQcDate': '2020-03-28', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of respiratory distress among patients admitted to the PICU.', 'timeFrame': 'baseline', 'description': 'The sensitivity and specificity of the lung ultrasound in identifying the etiology of respiratory distress will be determined by comparison with bedside chest x ray.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Respiratory Diseases']}, 'referencesModule': {'references': [{'pmid': '31238368', 'type': 'BACKGROUND', 'citation': 'Quercia M, Panza R, Calderoni G, Di Mauro A, Laforgia N. Lung Ultrasound: A New Tool in the Management of Congenital Lung Malformation. Am J Perinatol. 2019 Jul;36(S 02):S99-S105. doi: 10.1055/s-0039-1692131. Epub 2019 Jun 25.'}, {'pmid': '23768893', 'type': 'BACKGROUND', 'citation': 'Supakul N, Karmazyn B. Ultrasound of the pediatric chest--the ins and outs. Semin Ultrasound CT MR. 2013 Jun;34(3):274-85. doi: 10.1053/j.sult.2012.12.001.'}, {'pmid': '22392031', 'type': 'BACKGROUND', 'citation': 'Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.'}, {'pmid': '17316468', 'type': 'BACKGROUND', 'citation': 'Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.'}, {'pmid': '25993984', 'type': 'BACKGROUND', 'citation': 'Basile V, Di Mauro A, Scalini E, Comes P, Lofu I, Mostert M, Tafuri S, Manzionna MM. Lung ultrasound: a useful tool in diagnosis and management of bronchiolitis. BMC Pediatr. 2015 May 21;15:63. doi: 10.1186/s12887-015-0380-1.'}]}, 'descriptionModule': {'briefSummary': 'The use of POCUS in pediatrics is gaining momentum, and whilst pediatric specific data remains limited when compared to adult critical care, there is growing pediatric evidence demonstrating the high sensitivity and specificity of lung POCUS in the diagnosis of pneumonia, bronchiolitis, pleural effusion and pneumothorax. the American Academy of Pediatrics policy statement cautions that "clinicians should be aware that point of care ultrasonography is better used as a rule in and not a rule out diagnostic modality".', 'detailedDescription': 'In recent years, the use of point-of-care ultrasound (PoCUS), understood as the bedside ultrasound examination of the patient by the physician in charge, has been increasing in paediatric patients for the investigation of pulmonary, pleural and diaphragmatic disease, following its use in adult patients, in whom the technique has been developing for more than a decade, and whose ultrasound semiotics can be safely extrapolated to the paediatric age group. The unossified costal cartilage and sternum and thinner adipose subcutaneous tissue in children provide ideal acoustic windows.\n\nThis study aims to compare the use of bedside lung US to portable chest X-ray regarding sensitivity, specificity, safety and accuracy in identifying the etiology of respiratory distress among children admitted to the PICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients age 1 month and less than 18 years old with a clinical diagnosis of acute respiratory distress admitted in PICU Assiut University Children Hospital either connected to mechanical ventilation or not.', 'genderDescription': 'up to 18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>1month \\& \\<18years old\n* All cases with clinically respiratory distress admitted in PICU Assiut University Children Hospital either connected to mechanical ventilation or not.\n\nExclusion Criteria:\n\n1. Neonate.\n2. Congenital anomalies of respiratory tract.\n3. Cardiac diseases either congenital or acquired.\n4. Traumatic patients.'}, 'identificationModule': {'nctId': 'NCT04328220', 'acronym': 'PICU', 'briefTitle': 'Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in Pediatric Intensive Care Unit (PICU) Compared to Chest X-ray', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in PICU Compared to Chest X-ray', 'orgStudyIdInfo': {'id': 'chest US in PICU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'chest ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Chest x-ray'], 'description': 'A point-of-care lung ultrasound exam will be performed within 24h of admission to PICU and serial follow up according to each case.\n\nchest x-ray will be performed for comparison with ultrasound findings.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zeinab Mohey Eldeen, Professor', 'role': 'CONTACT', 'email': 'Zeinabmohieldeen1957@gmail.com', 'phone': '01028868829'}, {'name': 'Duaa Rafaat, Assistant Prof', 'role': 'CONTACT', 'email': 'duaa_raafat@aun.edu.eg', 'phone': '01223112124'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principlal investigator', 'investigatorFullName': 'Mahmoud Kotb', 'investigatorAffiliation': 'Assiut University'}}}}