Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-27 @ 3:16 PM
Study NCT ID:
NCT05856032
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2023-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Acapella With Conventional Chest Physiotherapy Techniques in Post CABG Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Participants will be blinded as they won't be knowing in which intervention group they are allocated."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-19', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Forced Expiratory Volume in 1 second', 'timeFrame': 'pre-operative day 1 and post-operative day 6 of CABG surgery', 'description': 'Forced expiratory volume in 1 second, measures the volume of air that is expired into the mouthpiece of the digital spirometer in first second after full inhalation. Normally ranges between 80% to 120% of average predicted values'}, {'measure': 'Change in Forced Vital Capacity', 'timeFrame': 'pre-operative day 1 and post-operative day 6 of CABG surgery', 'description': 'FVC: forced vital capacity, measures the volume of air blown forcefully into the mouthpiece following full inhalation. Normal values ranges between 80% to 120% of average predicted values'}, {'measure': 'Ratio of Forced Expiratory Volume in 1 second and Forced Vital Capacity', 'timeFrame': 'pre-operative day 1 and post-operative day 6 of CABG surgery', 'description': 'FEV1/FVC: the FEV1/FVC ratio is calculated by dividing measured FEV1 value by measured FVC value. In a healthy individual it ranges between 70 to 85%.'}], 'secondaryOutcomes': [{'measure': 'Borg dyspnoea scale', 'timeFrame': '6th post-operative day after CABG surgery', 'description': 'A scale used to measure level of exhaustion, breathlessness and fatigue during physical work. Patients are asked to rate the level of physical exertion, fatigue and dyspnoea on a 6-20 scale where 6 shows no fatigue at all and 20 indicates maximum exertion and fatigue.'}, {'measure': 'Amount of secretions expectorated', 'timeFrame': '6th post-operative day after CABG surgery', 'description': 'tracing the amount of pulmonary secretions produced per day as a result of using respiratory aids along with conventional chest physiotherapy techniques.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Procedure Complication']}, 'descriptionModule': {'briefSummary': 'To determine the effects of using Acapella as an oscillatory positive expiratory pressure device in combination with conventional chest physiotherapy for secretion removal and revival of pulmonary functions in hospitalized post coronary artery bypass grafting patients.', 'detailedDescription': 'Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anesthesia and muscle relaxants administered prior to surgery. Ciliary motion along the pathway of pulmonary tract is depressed which results in decrease expectoration capacity, causes mucus retention and reduces pulmonary volumes and capacities. Chest physiotherapy is the treatment option for such patients that is being practiced over years. In recent years certain respiratory aids or devices are also in use to relieve secretion retention along with standard chest physiotherapy techniques.\n\nThe purpose of this study is to find the effects of using Acapella as an OPEP device along with conventional chest physiotherapy techniques in post-CABG surgery patients to relieve mucus retention and improving pulmonary functions post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders within age range of 45-65 years\n* Elective CABG surgery patients\n* Patients undergoing Phase 1 cardiac rehabilitation post CABG\n* Patients who are vitally stable post operatively\n\nExclusion Criteria:\n\n* Patient having prolong intubation period post-operatively\n* Patients having long term arrythmias prior to surgery\n* Patients having an implanted pacemaker\n* Patients having uncontrolled diabetes, sepsis or any metabolic condition\n* Patients with impaired cognition.'}, 'identificationModule': {'nctId': 'NCT05856032', 'briefTitle': 'Effects of Acapella With Conventional Chest Physiotherapy Techniques in Post CABG Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Using Acapella in Combination With Conventional Chest Physiotherapy Techniques to Improve Pulmonary Functions in Post CABG Patients.', 'orgStudyIdInfo': {'id': 'REC/MS-PT/01494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of Acapella device', 'description': '* Experimental group will receive treatment with Acapella device twice a day for 6 days post-operatively.\n* Participants in this group will also receive conventional chest physiotherapy protocol as: incentive spirometry, Active Cycles of Breathing Technique (ACBT), Diaphragmatic breathing exercises except manual chest physiotherapy techniques.', 'interventionNames': ['Device: Acapella device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': "•Participants in control or comparative group will receive conventional chest physiotherapy protocol as incentive spirometry, ACBT's, Diaphragmatic breathing exercises along with manual chest physiotherapy techniques as percussion and vibration.", 'interventionNames': ['Other: Conventional Treatment']}], 'interventions': [{'name': 'Acapella device', 'type': 'DEVICE', 'description': 'Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anaesthesia and muscle relaxants administered prior to surgery.', 'armGroupLabels': ['Use of Acapella device']}, {'name': 'Conventional Treatment', 'type': 'OTHER', 'description': 'Conventional chest physiotherapy techniques', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Armed Forces Institute of Cardiology', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Malik Muhammad Ali Awan, MSPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}