Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06910020
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2025-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-08', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atelectasis', 'timeFrame': 'The first three postoperative days', 'description': 'Atelectasis will be assessed using chest X-rays.'}, {'measure': 'Dyspnea', 'timeFrame': 'The first three postoperative days', 'description': 'Dyspnea level will be assessed using the modified Borg scale.'}, {'measure': 'Functional capacity', 'timeFrame': 'The first three postoperative days', 'description': 'Functional capacity will be assessed using the six-minute walk test'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'The first three postoperative days', 'description': 'Hemodynamic parameters will include respiratory rate expressed as the number of cycles per minute, which will be assessed using the cardiac monitor'}, {'measure': 'Chest expansion', 'timeFrame': 'The first three postoperative days', 'description': 'Chest expansion will be measured at three points (axillary, xiphoid point, and umbilical level) using a measuring tape in centimeters.'}, {'measure': 'Duration of chest tube', 'timeFrame': 'Up to 1 week', 'description': 'Duration of chest tube'}, {'measure': 'Length of ICU stay', 'timeFrame': 'For up to 1 week', 'description': "Measure the duration of the patient's ICU stay"}, {'measure': 'Hemodynamic Parameters', 'timeFrame': 'For the first three postoperative days', 'description': 'Hemodynamic parameters will include oxygen saturation, which will be assessed using the pulse oximeter and will be expressed as a percentage %'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CABG', 'ACBT', 'Postoperative Pulmonary Complications', 'Chest tube duration', 'Hemodynamic parameters', 'Chest expansion'], 'conditions': ['Coronary Artery Bypass', 'Coronary Arterial Disease (CAD)']}, 'descriptionModule': {'briefSummary': "Following CABG surgery, patients are at risk for several complications. One of the most common complications is postoperative pulmonary complications, which include atelectasis and dyspnea. These complications cause prolonged ICU length of stay and increased health care costs. Several studies recommended the active cycle of breathing technique as a method that increases secretion removal and improves lung functions, thus reducing the incidence of postoperative pulmonary complications. Our study aims to investigate the effect of the active cycle of breathing technique on coronary artery bypass graft patients' outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient who will undergo CABG\n\nExclusion Criteria:\n\n* Mechanically ventilated patients on the first postoperative day.\n* Patients with preoperative lung collapse or pleural effusion.'}, 'identificationModule': {'nctId': 'NCT06910020', 'briefTitle': "Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes", 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': "Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes", 'orgStudyIdInfo': {'id': '320'}, 'secondaryIdInfos': [{'id': '320', 'type': 'REGISTRY', 'domain': 'Ethical Committee, Faculty of Nursing, Mansoura University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Cycle of Breathing Technique', 'description': 'Patients who will perform ACBT exercises in addition to the routine ICU care.', 'interventionNames': ['Other: Active Cycle of Breathing Technique']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients who will receive routine ICU care (chest physiotherapy and incentive spirometer) without ACBT.'}], 'interventions': [{'name': 'Active Cycle of Breathing Technique', 'type': 'OTHER', 'description': '* Patients will assume the sitting position and relax their shoulders, then perform the following:\n\n 1. Breathing control (abdominal breathing)\n 2. Chest expansion (thoracic breathing)\n 3. Huff cough (forced expiratory technique)\n* After completing the above actions, patients will be asked to cough up the residual deep sputum to promote pulmonary expansion.\n* The ACBT intervention will be performed for three days, each day two sessions, each session three courses, with 10 minutes of rest between them as needed.', 'armGroupLabels': ['Active Cycle of Breathing Technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dakahliya', 'country': 'Egypt', 'facility': 'Cardiothoracic and Vascular Surgery Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator of Critical Care and Emergency Nursing', 'investigatorFullName': 'Shaimaa Nagi Abdelkader Yousef', 'investigatorAffiliation': 'Mansoura University'}}}}