Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04446520
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2020-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-06-21', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial blood gases', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autogenic drainage', 'blood gases', 'Pneumonia,', 'upper abdominal surgery', 'Postoperative pulmonary Complications'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '34787294', 'type': 'DERIVED', 'citation': 'Taha MM, Draz RS, Gamal MM, Ibrahim ZM. Adding autogenic drainage to chest physiotherapy after upper abdominal surgery: effect on blood gases and pulmonary complications prevention. Randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):556-563. doi: 10.1590/1516-3180.2021.0048.0904221. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)', 'detailedDescription': 'Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 50 to 60 years\n* Patients undergoing elective upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.\n* Non-smoker patients\n\nExclusion Criteria:\n\n* Patients developing cancer\n* Patients with rib fractures\n* Inability to comprehend and follow instructions.\n* Pre-existing obstructive sleep apnea\n* Current hospital patient for a separate episode of care.\n* Patients requiring esophageal surgery or organ transplant.'}, 'identificationModule': {'nctId': 'NCT04446520', 'briefTitle': 'Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery', 'orgStudyIdInfo': {'id': 'P.T REC/012/001740'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autogenic drainage and traditional physiotherapy', 'description': 'autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)', 'interventionNames': ['Procedure: autogenic drainage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional physiotherapy', 'description': 'traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)', 'interventionNames': ['Procedure: autogenic drainage']}], 'interventions': [{'name': 'autogenic drainage', 'type': 'PROCEDURE', 'description': 'breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)', 'armGroupLabels': ['autogenic drainage and traditional physiotherapy', 'traditional physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11711', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alaini', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mona Taha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Princess Nourah Bint Abdulrahman University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'Mona Mohamed Taha', 'investigatorAffiliation': 'Cairo University'}}}}