Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT03872167
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2019-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial pressure of carbon dioxide (PaCO2)', 'timeFrame': 'two weeks', 'description': 'Measure levels after each polysomnography using arterial blood gases'}, {'measure': 'Partial pressure of oxygen (PaO2)', 'timeFrame': 'two weeks', 'description': 'Measure levels after each polysomnography using arterial blood gases'}], 'secondaryOutcomes': [{'measure': 'Oxygen saving time below 90% (CT90%)', 'timeFrame': 'one month', 'description': 'Assess the polysomnography reduction in CT90% through the night study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NIV', 'hypoxemia', 'hypercapnia'], 'conditions': ['Hypoxemic Respiratory Failure', 'Hypercapnic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.', 'detailedDescription': "Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: chronic respiratory failure\n\n* Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% \\>10%)\n\nExclusion Criteria:\n\n* Under 18 years old.\n* Presence of severe uncontrolled cardiac comorbidity.\n* Impossibility to achieve adaptation to therapy in the training session.'}, 'identificationModule': {'nctId': 'NCT03872167', 'briefTitle': 'Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.', 'orgStudyIdInfo': {'id': 'NIVHCLINIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MANUAL', 'description': 'Manual titration of non-invasive mechanical ventilation using polysomnography and randomized', 'interventionNames': ['Device: BIPAP, manual tritration.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AUTOMATIC', 'description': 'Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.', 'interventionNames': ['Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support']}], 'interventions': [{'name': 'BIPAP, Intelligent automatic mode defined by assured volume with pressure support', 'type': 'DEVICE', 'description': 'Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support', 'armGroupLabels': ['AUTOMATIC']}, {'name': 'BIPAP, manual tritration.', 'type': 'DEVICE', 'description': 'Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.', 'armGroupLabels': ['MANUAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'CRISTINA EMBID LOPEZ, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic'}, {'name': 'MONICA C MATUTE VILLACIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'CRISTINA EMBID LOPEZ', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}