Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03278769
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilator Settings on Patients With Acute Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], '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'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-01', 'size': 333046, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-16T11:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial pressure', 'timeFrame': '120 minutes', 'description': 'intracranial pressure increase with lung protective setting'}, {'measure': 'pressure reactivity index', 'timeFrame': '120 minutes', 'description': 'Diminished pressure reactivity index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Brain Injury', 'Ventilator-Induced Lung Injury', 'Cerebrovascular Circulation']}, 'referencesModule': {'references': [{'pmid': '19388307', 'type': 'BACKGROUND', 'citation': 'Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.'}, {'pmid': '26855895', 'type': 'BACKGROUND', 'citation': 'Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.'}, {'pmid': '27334266', 'type': 'BACKGROUND', 'citation': 'Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.'}, {'pmid': '36941683', 'type': 'DERIVED', 'citation': 'Beqiri E, Smielewski P, Guerin C, Czosnyka M, Robba C, Bjertnaes L, Frisvold SK. Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study. Crit Care. 2023 Mar 20;27(1):115. doi: 10.1186/s13054-023-04383-z.'}]}, 'descriptionModule': {'briefSummary': 'The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.', 'detailedDescription': 'The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.\n\nThe primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.\n\n1. increase intracranial pressure\n2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.\n\nThe secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Any tracheally intubated or tracheotomized adult patient with ABI with GCS\\< 9 on controlled ventilation requiring continuous ICP measurement.\n* Proxy informed consent from relatives.\n\nExclusion Criteria:\n\n* • ICP \\> 22 mmHg before treatment of high ICP\n* Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio \\< 40 kPa and Xray pathology\n* History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.\n* Body mass index (BMI) \\> 35.\n* Known right or biventricular cardiac failure with cardiac index \\< 2,5 L/min/m2 or ejection fracture \\< 40 %.\n* Refractory hypovolemia as diagnosed with pulse pressure variation \\> 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with \\> 10 % increase in stroke volume measured by VTI echocardiography or PICCO.\n* Medulla lesion that affect the autonomic nervous system.\n* Patients who has undergone decompressive craniectomy.'}, 'identificationModule': {'nctId': 'NCT03278769', 'briefTitle': 'Ventilator Settings on Patients With Acute Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients', 'orgStudyIdInfo': {'id': 'Brain-Vent'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventilator setting', 'description': 'Positive end-expiratory pressure , Tidal volume', 'interventionNames': ['Procedure: Lung protective ventilator settings']}], 'interventions': [{'name': 'Lung protective ventilator settings', 'type': 'PROCEDURE', 'description': 'Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight', 'armGroupLabels': ['Ventilator setting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9010', 'city': 'Tromsø', 'state': 'Troms', 'country': 'Norway', 'facility': 'University Hospital North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Shirin K Frisvold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Hôpital de la Croix-Rousse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, PhD', 'investigatorFullName': 'Shirin Kordasti Frisvold', 'investigatorAffiliation': 'University Hospital of North Norway'}}}}