Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-05 @ 7:23 PM
Study NCT ID:
NCT06036732
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D015192', 'term': 'Infratentorial Neoplasms'}, {'id': 'D001139', 'term': 'Arnold-Chiari Malformation'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 223}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay in ICU', 'timeFrame': 'From hospitalization to hospital discharge, estimated average = 10 days', 'description': 'Length of neuro ICU follow-up period'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'From hospitalization to hospital discharge, estimated average = 10 days', 'description': 'Length of hospital follow-up period'}], 'primaryOutcomes': [{'measure': 'Change in FIVE Scores', 'timeFrame': 'baseline, 12 hours intervals, up to an hour of ICU discharge', 'description': 'Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation'}, {'measure': 'Change in GKS Scores', 'timeFrame': 'baseline, 12 hours intervals, up to an hour of ICU discharge', 'description': 'Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation'}, {'measure': 'Modified Rankin Scale', 'timeFrame': 'six months after ICU discharge', 'description': 'In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FIVE Score', 'FOUR Score', 'GCS', 'Modified Rankin Score', 'Neuro-ICU'], 'conditions': ['Postoperative Intracranial Hematoma', 'Postoperative Intracranial Haemorrhage', 'Supratentorial Cancer', 'Infratentorial Neoplasms', 'Arnold Chiari Malformation', 'Subarachnoid Hemorrhage', 'Traumatic Brain Injury', 'Epilepsy, Temporal Lobe', 'Cerebrovascular Event', 'Intensive Care Neurological Disorder', 'Coma', 'Unconsciousness', 'Assessment, Self']}, 'descriptionModule': {'briefSummary': '1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.\n2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores', 'detailedDescription': 'Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.\n\nIn this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.\n\nThe demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.\n\nThe GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.\n\nThe length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.\n\nThe primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. The secondary objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients between the ages of 18 and 80, who were monitored in the Neurosurgical Intensive Care Unit and had a history of ischemic or hemorrhagic stroke within the last 6 months, underwent infratentorial craniotomy, supratentorial craniotomy, endoscopic surgery, vascular surgery, epilepsy surgery, hydrocephalus surgery, or neurovascular intervention, were included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 18 and 80\n* who were monitored in the Neurosurgical Intensive Care Unit\n* had a history of ischemic or hemorrhagic stroke within the last 6 months\n* underwent infratentorial craniotomy\n* supratentorial craniotomy\n* endoscopic surgery\n* vascular surgery\n* epilepsy surgery\n* hydrocephalus surgery\n* neurovascular intervention\n\nExclusion Criteria:\n\n* patients over 80 years of age\n* under 18 years of age\n* patients who were sedated\n* patients who were administered neuromuscular blockers during intensive care follow-up\n* patients with diagnosed psychiatric illness\n* patients who were alcohol or drug addicts'}, 'identificationModule': {'nctId': 'NCT06036732', 'briefTitle': 'A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study', 'orgStudyIdInfo': {'id': 'E-72109855-604.01.01-7591'}}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Tugba Ozfidan Donmez, MD', 'role': 'CONTACT', 'email': 'mtozfidann@gmail.com', 'phone': '00905056444156'}], 'facility': 'Istanbul University- Cerrahpasa(IUC)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Merve Tugba Ozfidan Donmez, MD', 'role': 'CONTACT', 'email': 'mtozfidann@gmail.com', 'phone': '00905056444156'}, {'name': 'Ozlem Korkmaz Dilmen, MD', 'role': 'CONTACT', 'email': 'korkmazdilmen@gmail.com', 'phone': '00905325801520'}], 'overallOfficials': [{'name': 'Ozlem Korkmaz Dilmen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'Yusuf Tunali, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'Fatma Eren Akcil, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'merve tugba ozfidan donmez', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}