Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT06090032
Status:
UNKNOWN
Last Update Posted:
2023-10-19
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compined SONOPULMONARY Infection Score and APACHE Score in RICU Patients With VAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome in RICU patients with ventilator associated pneumonia', 'timeFrame': 'One year', 'description': 'Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome of respiratory intensive care unit patients with ventilator associated pneumonia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8830125/', 'label': 'The National Institute for Health and Care Excellence (NICE), Pneumonia in adults: diagnosis and management. 2019'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/20597663/', 'label': '3\\. (Klevens RM, Edwards JR, Richards CL, et al. Estimating health careassociated infections and deaths in U.S. hospitals, 2002, Public Health Rep, 2007, vol. 122 (pg. 160-166).'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991773/', 'label': '4\\. Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A et al. Lung ultrasound for early diagnosis of ventilator-associated pneumonia. Chest. 2016;;149((4):969--980.. doi: 10.1016/j.chest.2015.12.012'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8225448/', 'label': '. Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: A physiologically based classification system. Crit Care Med. 1981;9:591-7.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study :\n\n1. Efficacy of Sono pulmonary infection score in combination with APACHE score in early diagnosis of VAP\n2. Assessment of prediction role of combined SIPS SCORE and APACHE SCORE of outcome of VAP patient in RICU\n3. Assessments of role of ultrasonography in early diagnosis and follow up of VAP', 'detailedDescription': 'Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively\\[1\\]. Ventilator associated pneumonia (VAP) is the most common and a leading cause of death in intensive care unit patient. Ventilator associated pneumonia is caused by prolonged duration of mechanical ventilation ,and prolonged hospital stay, which increase hospital costs, possibly increase mortality rate, and increase antibiotic use in ICU patients , early identification of VAP is an important clinical goal to improve patient outcomes \\[2\\]. In recent year several scoring systems have been developed to evaluate the severity of illness and to predict the outcome, especially the mortality rate of intensive care unit patient, such as the Clinical pulmonary infection score (CPIS) or modified (CPIS)The Clinical Pulmonary Infection Score (CPIS) was developed to serves a tool to facilitate the diagnosis of ventilator-associated pneumonia (VAP),The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation mpairment) ,a CPIS has an average between 0-12\\>6 some studies suggest that CPIS \\>6 may correlate with VAP Sonar is easy bedside test to diagnose pleural effusion, pneumonia pneumothorax , so recently lung ultrasonography (LUS) incorporated in evaluation and diagnosis of VAP in a new score called sono pulmonary infection score (SPIS) . The (SPIS), where is incorporated LUS finding instead of CXR finding of CPIS is assigned two points for ≥ one area of dynamic air bronchogram. One point was given for ≥ two sub-pleural consolidation or lobar consolidation areas or ≥ one sub-pleural, and ≥one lobar consolidationRecently (combination of SPIS with APACHE score in assessment of VAP is under research ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients after first 48 hours of admission in RICU .', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18 yrs\n2. Mechanically ventilated patients after first 48 hours of admission in RICU\n\nExclusion Criteria:\n\n1. Age \\<18 yrs\n2. Patients already diagnosed pneumonia\n3. Malignancy\n4. patient refused participation in the study.'}, 'identificationModule': {'nctId': 'NCT06090032', 'briefTitle': 'Compined SONOPULMONARY Infection Score and APACHE Score in RICU Patients With VAP', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Copmined Sono-pulmonary Score and APACHE Score as a Predictor of Outcome in Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia', 'orgStudyIdInfo': {'id': 'Chest U/S in RICU PT WITH VAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'We will use ultrasongraphy as a part of assessment in respiratory intensive care unit patients with ventilator associated pneumonia'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lamiaa hussein Fouda, Master', 'role': 'CONTACT', 'email': 'Lamiaahussein5@gmail.com', 'phone': '01140705774'}, {'name': 'Sahar farghly youssif', 'role': 'CONTACT', 'email': 'Saherfr2009@yahoo.com', 'phone': '+201002976708'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Lamiaa Hussein Fouda', 'investigatorAffiliation': 'Assiut University'}}}}