Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 8:30 PM
Study NCT ID:
NCT05044559
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial Blood Gasses', 'timeFrame': '3 days', 'description': "measures oxygen and carbon dioxide levels in your blood. It also measures your body's acid-base (pH) level, which is normally balanced when you are healthy."}], 'secondaryOutcomes': [{'measure': '6 minute walk test', 'timeFrame': '3 days', 'description': 'gold standard test to measure exercise capacity and requires less physical space and allows for easier monitoring of vital parameters'}, {'measure': 'Ejection Fraction', 'timeFrame': '4 week', 'description': 'expressed as a percentage, of how much blood the left ventricle pumps out with each contraction.'}, {'measure': 'Short Form 12 Questionnaire', 'timeFrame': '4 weeks', 'description': 'measuring tool for mental and physical health components. It consists of 12 questions which cover the eight health domain with one or two question per domain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous Positive Airway Pressure', 'Coronary Artery Bypass Graft Surgery', 'Inpatients Rehabilitations'], 'conditions': ['Post-cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.', 'detailedDescription': 'The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 35 to 60 years.\n* With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)\n\nExclusion Criteria:\n\n* Low ejection friction (15%)\n* Patient those who have any arrhythmias\n* Unstable angina\n* Patient having pace maker and implantable cardioverter defibrillator\n* COPD and asthmatic patient\n* Patient having BMI more then 40'}, 'identificationModule': {'nctId': 'NCT05044559', 'briefTitle': 'Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure in Phase 1 Cardiac Rehabilitation After Post CABG', 'orgStudyIdInfo': {'id': 'REC/00593 Memoona Salal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Positive Air Way Group', 'description': 'Day 1: Use of CPAP between 10 and 12 cmH2O according to tolerance for 20 minutes two time a day at first day of post surgery bed mobility chest physiotherapy ,active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise. and vital was record after exercise.\n\nDay 2: Active ROM exercise progress of 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time was increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.', 'interventionNames': ['Other: Continuous Positive Air Way Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise.\n\nDay 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Continuous Positive Air Way Group', 'type': 'OTHER', 'description': 'CPAP between 10 and 12 cmH2O', 'armGroupLabels': ['Continuous Positive Air Way Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise.\n\nDay 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Northwest General Hospital and research center', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Sumaiyah Obaid, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}