Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00143494
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-24', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the bladder pressure', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critically Ill Patients']}, 'referencesModule': {'references': [{'pmid': '17655744', 'type': 'RESULT', 'citation': 'Chiumello D, Tallarini F, Chierichetti M, Polli F, Li Bassi G, Motta G, Azzari S, Carsenzola C, Gattinoni L. The effect of different volumes and temperatures of saline on the bladder pressure measurement in critically ill patients. Crit Care. 2007;11(4):R82. doi: 10.1186/cc6080.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the bladder pressure to the gastric pressure in critically ill patients.', 'detailedDescription': 'In critically ill patients, we will measure the gastric pressure by a gastric balloon and the bladder pressure by the intra-vesical pressure to find the optimal method to estimate the abdominal pressure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients during invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Contraindication to measure the bladder pressure'}, 'identificationModule': {'nctId': 'NCT00143494', 'briefTitle': 'The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure', 'orgStudyIdInfo': {'id': '1200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Critically hill, mechanically ventilated patients', 'interventionNames': ['Procedure: measurement of abdominal pressure']}], 'interventions': [{'name': 'measurement of abdominal pressure', 'type': 'PROCEDURE', 'description': 'measurement of abdominal pressure with different volume and saline temperature', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Policlinico Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'davide chiumello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Davide Chiumello', 'oldOrganization': 'Policlinico Hospital'}}}}