Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05794867
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2023-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonic Weaning Criteria in Prolonged Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients who had no failure of weaning', 'timeFrame': '6 days', 'description': 'patients followed by ultrasounds criteria'}], 'secondaryOutcomes': [{'measure': 'The number of patients who discharged early from ICU', 'timeFrame': '6 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'compare and evaluate the effect of use of ultrasonic criteria of weaning versus the conventional ways of weaning in post-traumatic acute respiratory distress syndrome (ARDS) patients who were ventilated for a long time. And compare their effect on the duration of ICU stay.', 'detailedDescription': 'It is a prospective double blind study done on total 200 patients. Who were weaned from ventilator after being ventilated for \\> one week due to respiratory failure. This respiratory failure was selected in our study to be from severe lung contusion and post-traumatic acute respiratory distress syndrome. Patients were randomly allocated in one of two groups each group contain 100 patients. Group A considered control group. Those patients weaned from the ventilator by the conventional criteria of weaning. While group B weaned from the ventilator by the ultrasound criteria of weaning. All patients weaned from both groups followed for six days for signs of failure of weaning ,signs of post-extubation respiratory failure. And number of patients who were re-ventilated and who discharged from ICU in both groups recorded and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'It is a prospective double blind study done on total 200 patients. Who were weaned from ventilator after being ventilated for \\> one week due to respiratory failure. This respiratory failure was selected in our study to be from severe lung contusion and post-traumatic acute respiratory distress syndrome.', 'genderDescription': 'both sex are allocated randomly in one of the two groups', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients between 18-65 years old,\n* with Acute respiratory distress syndrome,\n* any ventilated patients for more than one week\n\nExclusion Criteria:\n\n* young or pediatric patients below 18 years.\n* patients older than 65 years\n* patients had Chronic Respiratory Disease'}, 'identificationModule': {'nctId': 'NCT05794867', 'briefTitle': 'Ultrasonic Weaning Criteria in Prolonged Ventilation', 'organization': {'class': 'NETWORK', 'fullName': 'King Abdul Aziz Specialist Hospital'}, 'officialTitle': 'Comparative Study Between Use of Ultrasonic Criteria of Weaning Versus the Conventional Criteria of Weaning in Post-traumatic Acute Respiratory Distress Syndrome Patients Who Were Ventilated for a Long Time', 'orgStudyIdInfo': {'id': 'icu- 4-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients were randomly allocated in one of two groups each group contain 100 patients.', 'description': 'Group A considered control group. Those patients weaned from the ventilator by the conventional criteria of weaning', 'interventionNames': ['Diagnostic Test: clinical weaning criteria']}, {'label': '100 patients', 'description': 'group B weaned from the ventilator by the ultrasound criteria of weaning. All patients weaned from both groups followed for six days for signs of failure of weaning ,signs of post-extubation respiratory failure. And number of patients who were re-ventilated and who discharged from ICU in both groups recorded and compared.'}], 'interventions': [{'name': 'clinical weaning criteria', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['arterial blood gases and reading on the ventilator'], 'description': 'Xray chest and calculation of thr rapid shallow breathing rate', 'armGroupLabels': ['Patients were randomly allocated in one of two groups each group contain 100 patients.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21944', 'city': "Ta'if", 'country': 'Saudi Arabia', 'facility': 'King abd el Aziz specialist hospital', 'geoPoint': {'lat': 21.27028, 'lon': 40.41583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the data is only laboratory data and figures read from the ventilator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdul Aziz Specialist Hospital', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}