Clinical trial NCT06036732: A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Keywords: FIVE Score
FOUR Score
GCS
Modified Rankin Score
Neuro-ICU
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in FIVE Scores
timeFrame: baseline, 12 hours intervals, up to an hour of ICU discharge
measure: Change in GKS Scores
timeFrame: baseline, 12 hours intervals, up to an hour of ICU discharge
measure: Modified Rankin Scale
timeFrame: six months after ICU discharge
Secondary outcomes:
Other outcomes:
measure: Length of stay in ICU
timeFrame: From hospitalization to hospital discharge, estimated average = 10 days
measure: Length of stay in hospital
timeFrame: From hospitalization to hospital discharge, estimated average = 10 days
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa(IUC)
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
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
References: