Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-18 @ 11:06 AM
Study NCT ID:
NCT06518759
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tidal volume', 'timeFrame': 'within 2 weeks', 'description': 'The spirometer device (Meditech, made in China) will be used to measure tidal volume for all participants in all groups before and after the treatment program. It is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures about 400 ml in a healthy female.'}, {'measure': 'Inspiratory reserve volume (IRV)', 'timeFrame': 'within 2 weeks', 'description': 'The spirometer device (Meditech, made in China) will be used to measure inspiratory reserve volume (IRV) for all participants in all groups before and after the treatment program.\n\n\\- IRV: It is the amount of air that can be forcibly inhaled after normal tidal volume. The normal adult value is 1900-3300 ml.'}, {'measure': 'Expiratory reserve volume (ERV)', 'timeFrame': 'within 2 weeks', 'description': 'The spirometer device (Meditech, made in China) will be used to measure expiratory reserve volume (ERV) for all participants in all groups before and after the treatment program.\n\nERV: It is the amount of extra air above normal breath-exhaled during forceful breath out, its average is about 800ml in females.'}, {'measure': 'Measurement of the potential of hydrogen (PH)', 'timeFrame': 'within 2 weeks', 'description': 'Blood gas analyzer will be used to measure the potential of hydrogen (PH) for all participants in all groups before and after the treatment program.\n\nThe blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.\n\nThe normative value of pH is7.35-7.45'}, {'measure': 'Measurement of the partial arterial pressure of carbon dioxide(PaCO2)', 'timeFrame': 'within 2 weeks', 'description': 'Blood gas analyzer will be used to measure the partial arterial pressure of carbon dioxide(PaCO2) for all participants in all groups before and after the treatment program.\n\nThe blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.\n\nthe normative value of PaCO2 is 4.7-6 KPa.'}, {'measure': 'Measurement of the partial arterial pressure of oxygen (PaO2)', 'timeFrame': 'within 2 weeks', 'description': 'Blood gas analyzer will be used to measure the partial arterial pressure of oxygen (PaO2)for all participants in all groups before and after the treatment program.\n\nThe blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.\n\nthe normative value of Pao2 is 1.7-13.3 KPa.'}, {'measure': 'Measurement of the Bicarbonate (HCO3)', 'timeFrame': 'within 2 weeks', 'description': 'Blood gas analyzer will be used to measure the Bicarbonate (HCO3) for all participants in all groups before and after the treatment program.\n\nThe blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.\n\nThe normative value of HCO3 is 22-26 mmol/L.'}, {'measure': 'Measurement of oxygen saturation (SO2)', 'timeFrame': 'within 2 weeks', 'description': 'Blood gas analyzer will be used to measure oxygen saturation (SO2) for all participants in all groups before and after the treatment program.\n\nThe blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.\n\nThe normative value of SO2 is 95-100%..'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery', 'detailedDescription': "Lung decortication is a well-known procedure for the treatment of empyema. Persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma.\n\nThere is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. So this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2\n* The patient will receive treatment after 24 hours after decortication\n* The study will be in the intensive care unit (ICU).\n* The patients have unilateral lung decortication\n* Their vital capacity is 70% or less.\n\nExclusion Criteria:\n\n* Cancerous patient.\n* Inability to comprehend and follow instructions as in dementia\n* paralytic involvement of thorax muscle\n* Abdominal diseases that affect diaphragmatic function\n* Diaphragmatic paralysis"}, 'identificationModule': {'nctId': 'NCT06518759', 'briefTitle': 'Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional chest techniques', 'description': 'the patients will receive traditional chest techniques only', 'interventionNames': ['Other: traditional chest techniques']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional chest techniques +Glossopharyngeal breathing exercise', 'description': 'the patients will receive traditional chest techniques and glossopharyngeal breathing exercise', 'interventionNames': ['Other: traditional chest techniques', 'Other: Glossopharyngeal breathing exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional chest techniques +diaphragmatic breathing exercise', 'description': 'the patients will receive traditional chest techniques and diaphragmatic breathing exercise', 'interventionNames': ['Other: traditional chest techniques', 'Other: Diaphragmatic breathing exercise']}], 'interventions': [{'name': 'traditional chest techniques', 'type': 'OTHER', 'description': 'patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks', 'armGroupLabels': ['Traditional chest techniques', 'Traditional chest techniques +Glossopharyngeal breathing exercise', 'Traditional chest techniques +diaphragmatic breathing exercise']}, {'name': 'Glossopharyngeal breathing exercise', 'type': 'OTHER', 'description': 'patients will receive Glossopharyngeal breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.', 'armGroupLabels': ['Traditional chest techniques +Glossopharyngeal breathing exercise']}, {'name': 'Diaphragmatic breathing exercise', 'type': 'OTHER', 'description': 'patients will receive diaphragmatic breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.', 'armGroupLabels': ['Traditional chest techniques +diaphragmatic breathing exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mai Gamal El-Din Mostafa', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nesreen El-Nahas, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mai Gamal El-Din Mostafa', 'investigatorAffiliation': 'Cairo University'}}}}