Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01382927
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2011-06-24', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial pO2 on room air', 'timeFrame': '24hrs'}, {'measure': 'Center of Ventilation', 'timeFrame': '24hrs', 'description': 'measured by EIT'}], 'secondaryOutcomes': [{'measure': 'Peak Flow', 'timeFrame': '24hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Hip Arthroplasty', 'General Anesthesia', 'Spinal Anesthesia', 'Atelectasis']}, 'descriptionModule': {'briefSummary': 'General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (EIT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese Patients aged 18-85, scheduled for elective hip arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>30\n* age 18-85\n* elective hip arthroplasty in general anesthesia or spinal anesthesia\n\nExclusion Criteria:\n\n* pregnancy/breastfeeding\n* allergies against drugs used for the anesthesia\n* contraindications for EIT\n* severe cardiac or pulmonary comorbidities\n* unable to consent or understand/follow study'}, 'identificationModule': {'nctId': 'NCT01382927', 'briefTitle': 'Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients', 'orgStudyIdInfo': {'id': 'SBVOBP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia'}, {'label': 'Spinal Anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Germany', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver C Radke, MD, PhD, DEAA', 'role': 'CONTACT', 'email': 'oradke@pcat.de', 'phone': '+49 351 458-18040'}, {'name': 'Oliver C Radke, MD, PhD, DEAA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Carl-Gustav-Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Oliver C. Radke, MD, PhD, DEAA', 'oldOrganization': 'Dpt of Anesthesia and Perioperative Care'}}}}