Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-13 @ 4:56 PM
Study NCT ID:
NCT01695603
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial pressure of carbon dioxide', 'description': 'The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}], 'secondaryOutcomes': [{'measure': 'Partial pressure of oxygen', 'description': 'The partial pressure of oxygen (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Number of alarms generated by the ventilator', 'description': 'The number of alarms generated by the ventilator will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Number of settings modifications', 'description': 'The number of ventilator settings modifications required will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Intracranial pressure', 'description': 'Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Respiratory parameters', 'description': 'Various respiratory parameters tidal volume, respiratory rate, minute ventilation, airway pressure) will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Cerebral vasoreactivity', 'description': 'Cerebral vasoreactivity will be studied from the intracranial pressure and invasive arterial pressure curves recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Partial pressure of oxygen in the brain tissue if available', 'description': 'Partial pressure of oxygen in the brain tissue, if available for clinical reasons, will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}, {'measure': 'Number of therapeutic actions needed to reduce intracranial pressure', 'description': 'The number of therapeutic actions needed to reduce intracranial pressure will be recorded during two hours under standard controlled ventilation and during two hours under Intellivent ventilation.'}, {'measure': 'Cerebral perfusion pressure', 'description': 'Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain injury', 'Controlled ventilation', 'Intellivent', 'Capnia control'], 'conditions': ['Brain Injured Patients']}, 'descriptionModule': {'briefSummary': 'Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)\n* Glasgow coma scale of 9 or less\n* Controlled mechanical ventilation required\n* Intracranial pressure monitoring required for clinical reasons\n\nExclusion Criteria:\n\n* age under 16 years old\n* clinical signs of brainstem lesions\n* patients with withdrawal order or for whom organ donation is under discussion\n* major haemodynamic instability\n* High carbon dioxide alveoloarterial gradient (\\>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 \\< 150 mmHg)\n* Patients included in another interventional clinical study'}, 'identificationModule': {'nctId': 'NCT01695603', 'briefTitle': 'Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients', 'orgStudyIdInfo': {'id': 'Intellibrain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard mode of controlled ventilation', 'description': 'Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.'}, {'type': 'EXPERIMENTAL', 'label': 'Intellivent arm', 'description': 'Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode.', 'interventionNames': ['Device: Intellivent']}], 'interventions': [{'name': 'Intellivent', 'type': 'DEVICE', 'armGroupLabels': ['Intellivent arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1012', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Adult Intensive Care and Burn Unit, University hospital of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Philippe Jolliet, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Philippe Jolliet', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Main investigator', 'investigatorFullName': 'Prof. Philippe Jolliet', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}