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

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06036732

Collaborator

(none)

223

Enrollment

Location

4.8

Anticipated Duration (Months)

46.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

223 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 25, 2024

Anticipated Study Completion Date :

Feb 25, 2024

Outcome Measures

Primary Outcome Measures

Change in FIVE Scores [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 [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 [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

Other Outcome Measures

Length of stay in ICU [From hospitalization to hospital discharge, estimated average = 10 days]
Length of neuro ICU follow-up period
Length of stay in hospital [From hospitalization to hospital discharge, estimated average = 10 days]
Length of hospital follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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