Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT02644733
Status:
UNKNOWN
Last Update Posted:
2017-02-08
First Post:
2015-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Body Position on Intraabdominal Pressure in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062885', 'term': 'Urinary Catheters'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2015-12-27', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine the effect of different body position on the intraabdominal pressure', 'timeFrame': 'up to 24 hour', 'description': 'the intraabdominal pressure will be measured by urinary catheter and nasogastric tube when the patient in semi-recumbent position at 30 head of bed elevation)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intraabdominal Hypertension']}, 'referencesModule': {'references': [{'pmid': '22873412', 'type': 'BACKGROUND', 'citation': 'Rooban N, Regli A, Davis WA, De Keulenaer BL. Comparing intra-abdominal pressures in different body positions via a urinary catheter and nasogastric tube: a pilot study. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S11. doi: 10.1186/2110-5820-2-S1-S11. Epub 2012 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'Measuring intraabdominal pressure in the semi-recumbent position and supine position.', 'detailedDescription': 'Each set of measurements of intraabdominal pressure included intra bladder and intragastric pressure in the supine position followed by the semi-recumbent position at head of bed 30. All four measurements were taken over a period of 5 to 10 min or less to reduce the possibility of changes in intraabdominal pressure over time. Three sets of readings were taken at least 4 h apart over a 24-h period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult mechanically ventilated patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nolder than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place\n\nExclusion Criteria:\n\n* recent oesophageal, gastric or bladder surgery; patients who were moribund and unlikely to survive 24 h; patients who were pregnant and patients who were unable to lay flat for any reason.'}, 'identificationModule': {'nctId': 'NCT02644733', 'acronym': 'Ghada', 'briefTitle': 'Effect of Different Body Position on Intraabdominal Pressure in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Lecturer in Critical Care Nursing Department', 'orgStudyIdInfo': {'id': 'Ghada22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'head of bed elevation 30 degree', 'type': 'PROCEDURE', 'otherNames': ['HOB30'], 'description': 'the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree'}, {'name': 'urinary catheter', 'type': 'PROCEDURE', 'otherNames': ['flat position'], 'description': 'the intraabdominal pressure will be measured by urinary catheter when the patient in supine position'}]}, 'contactsLocationsModule': {'locations': [{'zip': '088', 'city': 'Asyut', 'state': 'Assuit', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada sh Khalaf, lecturer', 'role': 'CONTACT', 'email': 'ghadashalaby66@yahoo.com', 'phone': '01062003314'}, {'name': 'Esam Ez Abd alhakiem', 'role': 'CONTACT'}], 'facility': 'Assuit university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '02', 'city': 'Egypt', 'state': 'Assuit', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada sh Khalaf, lecturer', 'role': 'CONTACT', 'email': 'ghadashalaby66@yahoo.com', 'phone': '01062003314'}, {'name': 'Esam Ez Abd alhakiem, Prof', 'role': 'CONTACT'}], 'facility': 'Faculty of Nursing'}], 'centralContacts': [{'name': 'Ghada Sh Khalaf, Lecturer', 'role': 'CONTACT', 'email': 'ghadashalaby66@yahoo.com'}, {'name': 'Sayed Ka Abd-elshaffy, professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ghada Sh Khalaf, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "the patient's assessment sheet will be used to collect the data by the researcher"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in critical care nursing department', 'investigatorFullName': 'Ghada Shalaby', 'investigatorAffiliation': 'Assiut University'}}}}