Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-02 @ 7:22 AM
Study NCT ID:
NCT07082361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Diaphragmatic Ultrasonography in Mechanical Ventilation Weaning Decision in COPD Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014886', 'term': 'Weaning'}], 'ancestors': [{'id': 'D007227', 'term': 'Infant Nutritional Physiological Phenomena'}, {'id': 'D002664', 'term': 'Child Nutritional Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with failed weaning trial', 'timeFrame': '28 day'}], 'secondaryOutcomes': [{'measure': 'Time till extubation trial.', 'timeFrame': '28 days'}, {'measure': 'Number of Intensive care unit discharges', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Diaphragmatic', 'Mechanical Ventilation', 'Weaning'], 'conditions': ['Ultrasonography', 'Mechanical Ventilation Weaning', 'Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.\n\nPrimary outcome:\n\n• Number of patients with failed weaning trial and need reintubation.\n\nSecondary outcomes:\n\n* Time till extubation trial.\n* Ventilation free days after extubation less or more than 48h .\n* Number of Intensive care unit discharges.\n* Sensitivity and specificity of diaphragmatic assessment as a predictor of weaning.', 'detailedDescription': "Chronic obstructive pulmonary disease is the fourth killer among all diseases worldwide. It can be prevented and treated, so it is an important public health challenge. Inspiratory muscle weakness has a great clinical association with Chronic obstructive pulmonary disease patients. The prolonged mechanical ventilation and weaning failure may be related to diaphragmatic muscle dysfunction. The traditional weaning parameters (e.g., spontaneous tidal volume ), Maximum inspiratory pressure , and rapid shallow breathing index are considered useful parameters for weaning. Although, they have unsatisfactory prediction rates.\n\nExacerbation of Chronic obstructive pulmonary disease is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management .\n\nIn most patients, mechanical ventilation can be discontinued as soon as the underlying reason for acute respiratory failure has been resolved. However, Patients spend receiving mechanical ventilation is devoted to weaning and increase up to, 59% in Chronic obstructive pulmonary disease patients .\n\nThere are innumerable factors responsible for the failure of weaning from mechanical ventilation. Factors that should be considered in all patients include misadjusted ventilator settings, infections, airway patency and respiratory muscle performance. Malnutrition, which is common in ventilator dependent patients, has detrimental effects on the respiratory system. Heart failure or coronary ischemia can be induced by the reduction of ventilatory support which causes weaning failure. A number of electrolyte imbalances and psychological problems can be an impediment to successful weaning.\n\nDiaphragmatic ultrasound is non-invasive, radiation-free, widely available, provides immediate and accurate results, and can be repeated at the bedside . Diaphragm sonography values provide useful information for assessing and monitoring mechanically ventilated patients .\n\nThe aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.\n\nA randomized controlled study will be carried out on patients admitted to Anesthesia \\& Surgical intensive care unit Department in Tanta University Hospitals over a period of 1 year"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient more than 21 years old of both sexes, coming to our intensive care unit with acute exacerbation of Chronic obstructive pulmonary disease \\& need mechanical ventilation at least 48 hr.\n\nExclusion Criteria:\n\n* Patient refusal.\n\n * Morbid obesity with body mass index \\> 35 kg/m2.\n * Patients with a history of recent thoracic surgery.\n * Neuromuscular disorders affecting the diaphragm e.g.(myopathy).\n * Congenital diaphragmatic disorders (Hiatal hernia).'}, 'identificationModule': {'nctId': 'NCT07082361', 'briefTitle': 'The Use of Diaphragmatic Ultrasonography in Mechanical Ventilation Weaning Decision in COPD Patient', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Use of Diaphragmatic Ultrasonography: Does It Change Mechanical Ventilation Weaning Decision and Predict Outcome in COPD Patient?', 'orgStudyIdInfo': {'id': '36264MS719/10/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing', 'description': 'Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials', 'interventionNames': ['Diagnostic Test: conventional clinical criteria and ultrasonic criteria for weaning']}, {'type': 'EXPERIMENTAL', 'label': 'conventional clinical criteria and ultrasonic criteria for weaning', 'description': 'Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.', 'interventionNames': ['Diagnostic Test: conventional clinical criteria of weaning from mechanical ventilation']}], 'interventions': [{'name': 'conventional clinical criteria of weaning from mechanical ventilation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials', 'armGroupLabels': ['conventional clinical criteria and ultrasonic criteria for weaning']}, {'name': 'conventional clinical criteria and ultrasonic criteria for weaning', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.', 'armGroupLabels': ['conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Shimaa Badr, Resident', 'role': 'CONTACT', 'email': 'aliaamohamedali@gmail.com', 'phone': '01099531489'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Shimaa Badr, Resident', 'role': 'CONTACT', 'email': 'ahmed.mostafa.hassan2023@gmail.com', 'phone': '+20 10 93734644'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Shimaa Adel Mohamed Helmy Badr', 'investigatorAffiliation': 'Tanta University'}}}}