Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT04144803
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2019-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Oxygenation During Prehospital Anesthesia: an Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Favorable neurological outcome', 'timeFrame': '30 days', 'description': 'modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)'}, {'measure': 'Cerebral desaturation event', 'timeFrame': 'through prehospital care, approximately 60 minutes', 'description': 'an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '30 days', 'description': 'Survival'}, {'measure': 'Survival', 'timeFrame': '365 days', 'description': 'Survival'}, {'measure': 'Favorable neurological outcome', 'timeFrame': '1 year', 'description': 'modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)'}, {'measure': '15D score', 'timeFrame': '1 year', 'description': "Heal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill', 'Major Trauma', 'Anesthesia', 'Emergencies']}, 'referencesModule': {'references': [{'pmid': '41359999', 'type': 'DERIVED', 'citation': 'Saviluoto A, Raatiniemi L, Makela S, Toivonen T, Setala P, Kirves H, Tommila M, Toivonen P, Tukia S, Nurmi J. Association of Cerebral Oxygenation During Prehospital Anaesthesia and Functional Outcome: A Prospective, Observational Multi-Centre Cohort Study of 1014 Patients. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70161. doi: 10.1111/aas.70161.'}]}, 'descriptionModule': {'briefSummary': 'Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason\n\nExclusion Criteria:\n\n* Ongoing cardiopulmonary resuscitation at the time of intubation\n* Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)\n* HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included)\n* Workload too high to ensure standard level of clinical care during the study\n* For interviews: no competence in Finnish, Swedish or English'}, 'identificationModule': {'nctId': 'NCT04144803', 'acronym': 'BOPRA', 'briefTitle': 'Brain Oxygenation During Prehospital Anesthesia: an Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)', 'orgStudyIdInfo': {'id': 'BOPRA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cerebral desaturation group', 'description': 'absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia', 'interventionNames': ['Diagnostic Test: Cerebral near-infrared spectroscopy']}, {'label': 'Control group', 'description': 'no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia', 'interventionNames': ['Diagnostic Test: Cerebral near-infrared spectroscopy']}], 'interventions': [{'name': 'Cerebral near-infrared spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital', 'armGroupLabels': ['Cerebral desaturation group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuopio', 'country': 'Finland', 'facility': 'FinnHEMS 60 / Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'FinnHEMS 50 / Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Rovaniemi', 'country': 'Finland', 'facility': 'FinnHEMS 51 / Lapland hospital district', 'geoPoint': {'lat': 66.49897, 'lon': 25.68867}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'FinnHEMS 30 / Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'FinnHEMS 20 / Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Vantaa', 'country': 'Finland', 'facility': 'FinnHEMS 10 / Helsinki University Hospital', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}], 'overallOfficials': [{'name': 'Jouni Nurmi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'FinnHEMS Ltd', 'class': 'UNKNOWN'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Lapland Hospital District', 'class': 'UNKNOWN'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Metropolia University of Applied Sciences', 'class': 'OTHER'}, {'name': 'Turku University of Applied Sciences', 'class': 'UNKNOWN'}, {'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Oulu University of Applied Sciences', 'class': 'UNKNOWN'}, {'name': 'Savonia University of Applied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jouni Nurmi, MD', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}