A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score
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| ClinicalTrials.gov Identifier: NCT06036732 |
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Recruitment Status :
Not yet recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
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- 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.
- 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
| Condition or disease |
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| 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 |
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.
In 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.
The 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.
The 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.
The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.
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. 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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 223 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | 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 |
| Estimated Study Start Date : | October 1, 2023 |
| Estimated Primary Completion Date : | January 25, 2024 |
| Estimated Study Completion Date : | February 25, 2024 |
- Change in FIVE Scores [ Time Frame: baseline, 12 hours intervals, up to an hour of ICU discharge ]Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation
- Change in GKS Scores [ Time Frame: baseline, 12 hours intervals, up to an hour of ICU discharge ]Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation
- Modified Rankin Scale [ Time Frame: six months after ICU discharge ]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
- Length of stay in ICU [ Time Frame: From hospitalization to hospital discharge, estimated average = 10 days ]Length of neuro ICU follow-up period
- Length of stay in hospital [ Time Frame: From hospitalization to hospital discharge, estimated average = 10 days ]Length of hospital follow-up period
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- between the ages of 18 and 80
- who were monitored in the Neurosurgical Intensive Care Unit
- 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
- neurovascular intervention
Exclusion Criteria:
- patients over 80 years of age
- under 18 years of age
- patients who were sedated
- patients who were administered neuromuscular blockers during intensive care follow-up
- patients with diagnosed psychiatric illness
- patients who were alcohol or drug addicts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036732
| Contact: Merve Tugba Ozfidan Donmez, MD | 00905056444156 | mtozfidann@gmail.com | |
| Contact: Ozlem Korkmaz Dilmen, MD | 00905325801520 | korkmazdilmen@gmail.com |
| Turkey | |
| Istanbul University- Cerrahpasa(IUC) | |
| Istanbul, Fatih, Turkey, 34098 | |
| Contact: Merve Tugba Ozfidan Donmez, MD 00905056444156 mtozfidann@gmail.com | |
| Study Chair: | Ozlem Korkmaz Dilmen, MD | Istanbul University - Cerrahpasa (IUC) | |
| Study Director: | Yusuf Tunali, MD | Istanbul University - Cerrahpasa (IUC) | |
| Study Director: | Fatma Eren Akcil, MD | Istanbul University - Cerrahpasa (IUC) |
| Responsible Party: | merve tugba ozfidan donmez, medical doctor, Istanbul University - Cerrahpasa (IUC) |
| ClinicalTrials.gov Identifier: | NCT06036732 |
| Other Study ID Numbers: |
E-72109855-604.01.01-7591 |
| First Posted: | September 14, 2023 Key Record Dates |
| Last Update Posted: | September 14, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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FIVE Score FOUR Score GCS Modified Rankin Score Neuro-ICU |
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Infratentorial Neoplasms Supratentorial Neoplasms Brain Injuries Brain Injuries, Traumatic Subarachnoid Hemorrhage Intracranial Hemorrhages Nervous System Diseases Arnold-Chiari Malformation Epilepsy, Temporal Lobe Unconsciousness Hemorrhage Hematoma Brain Diseases Central Nervous System Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Epilepsy Pathologic Processes Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Congenital Abnormalities Neural Tube Defects Nervous System Malformations Epilepsies, Partial Epileptic Syndromes Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |