Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04432051
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Lung Ultrasonography in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients will be divided into two groups, those with and without ultrasound.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PO2 values', 'timeFrame': '12 hours', 'description': 'Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.'}], 'secondaryOutcomes': [{'measure': 'Change in PCO2 values', 'timeFrame': '12 hours', 'description': 'Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung ultrasonography', 'intensive care unit', 'position', 'COVID-19'], 'conditions': ['Ultrasonography']}, 'descriptionModule': {'briefSummary': 'In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.', 'detailedDescription': 'In this study, the COVID-19 patients hospitalized in the intensive care unit due to respiratory failure will be evaluated. Participants will be divided into two groups as patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung ultrasonography (Group Control).\n\nWhile performing lung ultrasonography, each hemithorax will be evaluated using anterior axillary line and posterior axillary line into anterior, lateral and posterior region, and each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with the Lung Ultrasound Score (LUS score).\n\nParticipants in both groups will be evaluated by comparing arterial blood gas analyzes before examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and ventilation between Group Ultrasonograpy and Group Control will be evaluated?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have been diagnosed with COVID 19\n* Patients in the intensive care unit over the age of 18\n\nExclusion Criteria:\n\n* Patients not diagnosed with COVID 19\n* Patients with cardiac problems\n* Patients with renal problems'}, 'identificationModule': {'nctId': 'NCT04432051', 'briefTitle': 'The Use of Lung Ultrasonography in COVID-19 Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure', 'orgStudyIdInfo': {'id': 'Gaziosmanpasa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GRUP Control', 'description': 'The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.', 'interventionNames': ['Behavioral: mechanical ventilator settings and position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GRUP Ultrasonography', 'description': 'The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.', 'interventionNames': ['Behavioral: mechanical ventilator settings and position']}], 'interventions': [{'name': 'mechanical ventilator settings and position', 'type': 'BEHAVIORAL', 'description': 'Mechanical ventilation settings and patient position will be re-evaluated', 'armGroupLabels': ['GRUP Control', 'GRUP Ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gazoosmanpasa Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}