Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00912158
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2009-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mahaghanem@hotmail.com', 'phone': '+ 2 0127694434', 'title': 'Dr. Maha K Ghanem, MD, FCCP', 'organization': 'Chest Department, Faculty of Medicine, Assiut University- EGYPT'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality', 'timeFrame': 'Hospital stay', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2010-01'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Were Intubated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP+ST', 'description': 'Continuous positive airway pressure plus standard medical therapy'}, {'id': 'OG001', 'title': 'BiPAP + ST', 'description': 'Bilevel positive airway pressure + standard medical therapy'}, {'id': 'OG002', 'title': 'Standard Treatment', 'description': 'Standard medical therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During ICU Stay', 'description': 'Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2008-11'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPAP+ST', 'description': 'Continuous positive airway pressure plus standard medical therapy'}, {'id': 'FG001', 'title': 'BiPAP + ST', 'description': 'Bilevel positive airway pressure + standard medical therapy'}, {'id': 'FG002', 'title': 'Standard Treatment', 'description': 'Standard medical therapy alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)', 'preAssignmentDetails': 'All enrolled participants were assigned to one of the three studied groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CPAP+ST', 'description': 'Continuous positive airway pressure plus standard medical therapy'}, {'id': 'BG001', 'title': 'BiPAP + ST', 'description': 'Bilevel positive airway pressure + standard medical therapy'}, {'id': 'BG002', 'title': 'Standard Treatment', 'description': 'Standard medical therapy alone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '68', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '69', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '67', 'spread': '4.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-17', 'studyFirstSubmitDate': '2009-04-08', 'resultsFirstSubmitDate': '2009-04-08', 'studyFirstSubmitQcDate': '2009-04-09', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-09', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Were Intubated', 'timeFrame': 'During ICU Stay', 'description': 'Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality', 'timeFrame': 'Hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CPE', 'CPAP', 'BiPAP', 'non invasive mechanical ventilation'], 'conditions': ['Acute Cardiogenic Pulmonary Edema']}, 'referencesModule': {'references': [{'pmid': '12441754', 'type': 'BACKGROUND', 'citation': 'Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009.'}, {'pmid': '18614781', 'type': 'BACKGROUND', 'citation': 'Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992.'}, {'pmid': '16210459', 'type': 'BACKGROUND', 'citation': 'Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229.'}, {'pmid': '18646124', 'type': 'RESULT', 'citation': 'Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2.'}], 'seeAlsoLinks': [{'url': 'http://www.medscape.com', 'label': 'Medscape: Free CME, Medical News, Full-text Journal Articles \\& More'}, {'url': 'http://www.pubMed.gov', 'label': 'U.S. National Library of Medicine \\& the National Institutes of Health'}, {'url': 'http://www.cochrane.org', 'label': 'The Cochrane library: Evidence for healthcare decision-making'}]}, 'descriptionModule': {'briefSummary': 'Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.', 'detailedDescription': 'To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CPE confirmed radiologically and/or clinically\n2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)\n3. Dyspnea of sudden onset with respiratory\n4. Systolic blood pressure \\< 180 mmHg\n\nExclusion Criteria:\n\n1. Immediate need for endotracheal intubation:\n\n * Severe sensorial impairment\n * Shock\n * Ventricular arrhythmias,\n * Life-threatening hypoxia (SpO2 \\[oxygen saturation as indicated by pulse oximetry\\] less than 80% with oxygen)\n * Acute myocardial infarction necessitating thrombolysis\n * Cardiac or respiratory arrest\n2. Severe chronic renal failure\n3. Pneumothorax.\n4. Contraindication of non invasive ventilation (NIV)'}, 'identificationModule': {'nctId': 'NCT00912158', 'briefTitle': 'Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients', 'orgStudyIdInfo': {'id': 'RICU, Assiut University 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP + ST', 'description': 'Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)', 'interventionNames': ['Device: CPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BiPAP + ST', 'description': 'Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)', 'interventionNames': ['Device: BIPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ST', 'description': 'Standard Medical therapy (ST)', 'interventionNames': ['Other: standard therapy (ST)']}], 'interventions': [{'name': 'standard therapy (ST)', 'type': 'OTHER', 'otherNames': ['Medical treatment of acute cardiogenic pulmonary oedema'], 'description': 'standard medical therapy', 'armGroupLabels': ['ST']}, {'name': 'CPAP', 'type': 'DEVICE', 'otherNames': ['Continuous postive air way pressure', 'noninvasive positive support ventilation (NPSV)'], 'description': 'Non-invasive mechanical ventilation (CPAP)', 'armGroupLabels': ['CPAP + ST']}, {'name': 'BIPAP', 'type': 'DEVICE', 'otherNames': ['Bilevel Positive Airway Pressure ventilation'], 'description': 'Non-invasive mechanical ventilation (BIPAP)', 'armGroupLabels': ['BiPAP + ST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Gamal M Agmy, MD, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chest Department, Faculty of Medicine-Assiut University'}, {'name': 'Maha K Ghanem, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chest Department, Faculty of Medicine- Assiut University'}, {'name': 'Hoda A Makhlouf, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chest Department, Faculty of Medicine- Assiut University'}, {'name': 'Amany O Mohamed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chest Department, Faculty of Medicine- Assiut University'}, {'name': 'Hamdy S Mohamed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiology Department, Faculty of Medicine- Assiut University'}, {'name': 'Hatem A Helmy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiology Department, Faculty of Medicine - Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Gamal R Agmy', 'oldOrganization': 'Faculty of Medicine, Assiut University'}}}}