Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT01239433
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2010-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intrabronchial airway pressure', 'timeFrame': '2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation.', 'detailedDescription': 'Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study such pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation. A systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. No additional study interventions are carried out.\n\nThe aim of the project is to examine negative effects of pressure/volume changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the Intensive Care Unit (ICU) on mechanical ventilation where daily endotracheal suctioning is performed to remove secretions.\n\nMost of the patients have ARDS/ ALI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* on mechanical ventilation\n* daily endotracheal suctioning performed\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* non-invasive ventilation'}, 'identificationModule': {'nctId': 'NCT01239433', 'briefTitle': 'Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions', 'orgStudyIdInfo': {'id': 'REK S-O, Ref 2010/1340, part B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mechanically ventilated patients', 'description': 'ICU patients on mechanical ventilation. Daily endotracheal suctioning performed to reduce secretions. Data recorded during these therapeutic interventions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital - Ulleval', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Espen R Nakstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital - Ulleval, Norway'}, {'name': 'Helge Opdahl, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ullevaal University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Espen Rostrup Nakstad', 'investigatorAffiliation': 'Oslo University Hospital'}}}}