Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:12 AM
Study NCT ID:
NCT07318766
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incentive Spirometer in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open label, parallel, prospective, randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial blood gas (ABG) parameters', 'timeFrame': '3 days (assessed at four time points: baseline (within 48 hours before surgery) and on post-operative days 1, 2, and 3)', 'description': 'Arterial pH'}, {'measure': 'Arterial Blood Gas (ABG) parameters', 'timeFrame': '3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1,2, and 3 post-surgery)', 'description': '(2) partial pressure of carbon dioxide (PCO2, mmHg)'}, {'measure': 'Arterial Blood Gas (ABG) parameters', 'timeFrame': '3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)', 'description': '(3) Partial pressure of oxygen (PO2, mmHg)'}, {'measure': 'Arterial Blood Gas (ABG) Parameters', 'timeFrame': '3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)', 'description': '(4) bicarbonate concentration (HCO3-, mEq/L)'}, {'measure': 'Arterial Blood Gas (ABG) Parameters', 'timeFrame': '3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)', 'description': '(5) Oxygen saturation (SpO2, %).'}], 'secondaryOutcomes': [{'measure': 'length of intensive care unit (ICU) stay', 'timeFrame': 'Perioperative period (Hospital stay duration)', 'description': 'The length of intensive care unit (ICU) stay (days)'}, {'measure': 'hospital stay', 'timeFrame': 'Perioperative period (Hospital Stay duration)', 'description': 'total length of hospital stay (days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Transplant', 'Incentive Spirometer', 'Arterial Blood Gas'], 'conditions': ['Liver Transplant Disorder']}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of adjunctive incentive spirometer on arterial blood gases (ABGs) and early postoperative recovery in liver transplant recipients.', 'detailedDescription': 'In this prospective , randomized study, 40 adults undergoing living-donor liver transplantation (LT) were assigned to standard post-transplant mobilization and breathing exercises alone (n=20) or standard exercises plus structured IS training (n=20). Arterial blood gases ABG parameters (pH, PO₂, PCO₂, HCO₃-, SpO₂) were measured at baseline and on postoperative days 1-3. Linear mixed-effects models assessed group differences in ABG trajectories; slope analyses quantified decline and recovery phases. Secondary outcomes included intensive care unit (ICU) and hospital length of stay (LOS) and Post-operative pulmonary complications incidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age between 18 and 65 years,\n2. scheduled to undergo Living Donor Liver Transplant (LDLT) as recipients\n3. able to understand and follow instructions for incentive spirometry use\n\nExclusion Criteria:\n\n1. multiorgan transplantation\n2. moderate-to-severe pleural effusion at baseline\n3. persistent elevation in renal function tests\n4. history of bleeding esophageal varices within the preceding month\n5. multicentric hepatocellular carcinoma (HCC)\n6. active smoking\n7. decompensated cardiac disease\n8. alcoholic hepatitis as the primary etiology\n9. cognitive impairment or blindness precluding participation in the rehabilitation protocol.'}, 'identificationModule': {'nctId': 'NCT07318766', 'acronym': 'LT', 'briefTitle': 'Incentive Spirometer in Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'HS000132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'mobilization and breathing exercises alone', 'description': 'Patients in the control group received standard post-transplant mobilization and breathing exercises as per institutional protocol. This included early mobilization, active limb exercises, and deep breathing exercises without the use of an intensive spirometry (IS) device. The exercise regimen was initiated on the first post-operative day and continued throughout the hospital stay.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incentive Spirometery plus standard exercises', 'description': 'Patients in the intervention group received structured training on Incentive spirometry (IS) use commencing on the first post-operative day. A tri-flow volumetric IS device was utilized', 'interventionNames': ['Device: Incentive Spirometry']}], 'interventions': [{'name': 'Incentive Spirometry', 'type': 'DEVICE', 'description': 'An intensive spirometry (IS) is a device that measures inhaled air volume and provides visual feedback as a piston rises during inspiration. It is widely used in respiratory and physical therapy to encourage slow, deep breathing, which helps expand the lungs, open airways, and mimic the natural deep breaths seen in yawning or sighing.', 'armGroupLabels': ['Incentive Spirometery plus standard exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'El Sahel Teaching hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mona A. Abdulmohsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El-Sahel Teaching Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'El-Sahel Teaching Hospital', 'class': 'OTHER_GOV'}, {'name': 'National Hepatology & Tropical Medicine Research Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Aya Mohammed Abdel Magid Abdel Hamid', 'investigatorAffiliation': 'Cairo University'}}}}