Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04502420
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Function After Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diffusion capacity for carbon monoxide (DLCO)', 'timeFrame': 'Change from baseline (the day before surgery) to postoperative day 1 or 2', 'description': 'Change in DLCO'}], 'secondaryOutcomes': [{'measure': 'Vital capacity (VC)', 'timeFrame': 'Change from baseline (the day before surgery) to postoperative day 1 or 2', 'description': 'Change in VC'}, {'measure': 'Forced expiratory volume (FEV1)', 'timeFrame': 'Change from baseline (the day before surgery) to postoperative day 1 or 2', 'description': 'Change in FEV1'}, {'measure': 'Arterial PO2', 'timeFrame': 'Change from baseline (the day before surgery) to postoperative day 1 or 2', 'description': 'Change in arterial PO2'}, {'measure': 'Arterial PCO2', 'timeFrame': 'Change from baseline (the day before surgery) to postoperative day 1 or 2', 'description': 'Change in arterial PCO2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung function', 'Diffusion capacity', 'Postoperative complications', 'Abdominal surgery'], 'conditions': ['Lung Function', 'Postoperative Complications', 'Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.\n\nInclusion: Patients undergoing surgery for abdominal surgery\n\nExclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.\n\nInvestigation: The day before surgery and the day after surgery\n\nPrimary outcome measures:\n\n* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.\n* PaO2, PaCO2 and oxygen saturation (blood gas)', 'detailedDescription': 'Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.\n\nThe study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.\n\nDesign: Prospective cohort study\n\nInclusion: Patients undergoing surgery for abdominal surgery\n\nExclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.\n\nMethod: The day before surgery and the day after surgery: Lung function (Vital capacity and FEV1) using box and diffusion capacity measurements and blood gas measurement\n\nPrimary outcome measures:\n\n* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.\n* PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery, previously known lung disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients of 18 years old or olderundergoing abdominal surgery at department of Surgery, Urology and Gynecologi Umeå University hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years old and older) scheduled for surgery in the abdomen at department of Surgery, Urology and Gynecologi, Umeå University hospital.\n* Must be able to perform a lung function test\n\nExclusion Criteria:\n\n• Dementia or severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04502420', 'briefTitle': 'Lung Function After Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery', 'orgStudyIdInfo': {'id': '2018-223-31M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abdominal surgery', 'description': 'People who to be operated in the abdomen are investigated before and after surgery.', 'interventionNames': ['Diagnostic Test: Lung function before and after surgery']}], 'interventions': [{'name': 'Lung function before and after surgery', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diffusion capacity and arterial blood gas before and after surgery.'], 'description': 'A diagnostic test', 'armGroupLabels': ['Abdominal surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'country': 'Sweden', 'facility': 'Dept surgery,', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Karl A Franklin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inst Surgical and periopertive sciences, Umeå university, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We plan to share IPD if possible according to Swedish legislation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karl A Franklin', 'investigatorAffiliation': 'Umeå University'}}}}