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A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06036732
Enrollment
223
Registered
2023-09-14
Start date
2023-10-01
Completion date
2024-02-25
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arnold Chiari Malformation, Assessment, Self, Cerebrovascular Event, Coma, Epilepsy, Temporal Lobe, Infratentorial Neoplasms, Intensive Care Neurological Disorder, Postoperative Intracranial Haemorrhage, Postoperative Intracranial Hematoma, Subarachnoid Hemorrhage, Supratentorial Cancer, Traumatic Brain Injury, Unconsciousness

Keywords

FIVE Score, FOUR Score, GCS, Modified Rankin Score, Neuro-ICU

Brief summary

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. 2. 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

Detailed description

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.

Interventions

None listed

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in FIVE Scoresbaseline, 12 hours intervals, up to an hour of ICU dischargeFull Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation
Change in GKS Scoresbaseline, 12 hours intervals, up to an hour of ICU dischargeGlasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation
Modified Rankin Scalesix months after ICU dischargeIn 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

Other

MeasureTime frameDescription
Length of stay in ICUFrom hospitalization to hospital discharge, estimated average = 10 daysLength of neuro ICU follow-up period
Length of stay in hospitalFrom hospitalization to hospital discharge, estimated average = 10 daysLength of hospital follow-up period

Countries

Turkey (Türkiye)

Contacts

Primary ContactMerve Tugba Ozfidan Donmez, MD
mtozfidann@gmail.com00905056444156
Backup ContactOzlem Korkmaz Dilmen, MD
korkmazdilmen@gmail.com00905325801520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026