Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 7:39 PM
Study NCT ID:
NCT00925860
Status:
COMPLETED
Last Update Posted:
2009-06-22
First Post:
2009-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Positive Pressure Ventilation in Hypoxemic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-19', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-19', 'lastUpdatePostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality rates', 'timeFrame': 'patient hospital discharge'}], 'secondaryOutcomes': [{'measure': 'oxygenation improve', 'timeFrame': 'patient hospital discharge'}, {'measure': 'diminishing of tracheal intubation incidence', 'timeFrame': 'patient hospital discharge'}, {'measure': 'ICU and Post ICU hospital length of stay', 'timeFrame': 'patient hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.', 'detailedDescription': 'Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dyspnea with respiratory rates higher than 35 p.m.\n* pO2 \\< 65 mmHg\n* paO2/FiO2 \\< 250\n\nExclusion Criteria:\n\n* respiratory or cardiac arrest\n* gastrointestinal bleeding\n* hemodynamic instability\n* face surgery\n* upper airway obstruction\n* inability for active cooperation\n* need for airway protection\n* exacerbation of COPD\n* decrease of conscious level\n* acute pulmonary cardiogenic oedema'}, 'identificationModule': {'nctId': 'NCT00925860', 'briefTitle': 'Non-Positive Pressure Ventilation in Hypoxemic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Provincial de Castellon'}, 'officialTitle': 'Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study', 'orgStudyIdInfo': {'id': 'HGCS-2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non invasive ventilation approach', 'description': 'pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation', 'interventionNames': ['Procedure: non positive pressure mechanical ventilatory support']}, {'type': 'NO_INTERVENTION', 'label': 'conventionally ventilated', 'description': 'pure hypoxemic patients treated by conventional ventilatory support'}], 'interventions': [{'name': 'non positive pressure mechanical ventilatory support', 'type': 'PROCEDURE', 'armGroupLabels': ['non invasive ventilation approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12004', 'city': 'Castelló', 'state': 'CASTELLO', 'country': 'Spain', 'facility': 'Intensive Care Department - General Hospital', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}], 'overallOfficials': [{'name': 'Alberto Belenguer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Provincial de Castellon', 'class': 'OTHER'}}}}