Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-20 @ 12:30 PM
Study NCT ID:
NCT02220959
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with successful extubation', 'timeFrame': 'postoperative 30 minutes', 'description': 'preoperative 60 meter walk test'}]}, 'conditionsModule': {'keywords': ['morbid obesity surgery', 'walk test', 'exercise'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients between 18-60 years old\n* patients with BMI \\> 40\n* patients undergoing Laparoscopic Sleeve Gastrectomy\n\nExclusion Criteria:\n\n* patients with Chronic obstructive pulmonary disease (COPD), Asthma,\n* patients with uncompensated heart failure\n* Uncompensated diabetes mellitus\n* Patients Who have orthopedic problems that effects the exercise test'}, 'identificationModule': {'nctId': 'NCT02220959', 'briefTitle': 'Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?', 'orgStudyIdInfo': {'id': '14467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walk test', 'description': 'morbid obese patients (BMI\\>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC)', 'interventionNames': ['Other: walk test']}], 'interventions': [{'name': 'walk test', 'type': 'OTHER', 'otherNames': ['60 meter walk test'], 'description': 'patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test', 'armGroupLabels': ['walk test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Cerrahpasa medical Faculty General surgery operation theatre', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Guniz M.Koksal', 'investigatorAffiliation': 'Istanbul University'}}}}