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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Unconsciousness; Traumatic Brain Injury; Subarachnoid Hemorrhage; Coma; Infratentorial Neoplasms; Epilepsy, Temporal Lobe; Assessment, Self; Intensive Care Neurological Disorder; Arnold Chiari Malformation; Cerebrovascular Event; Postoperative Intracranial Hematoma; Postoperative Intracranial Haemorrhage; Supratentorial Cancer

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 Type: Observational
• Enrollment (Estimated): 223

Contacts and Locations

• Study Contact: Name: Merve Tugba Ozfidan Donmez, MD; Phone Number: 00905056444156; Email: mtozfidann@gmail.com
• Study Contact Backup: Name: Ozlem Korkmaz Dilmen, MD; Phone Number: 00905325801520; Email: korkmazdilmen@gmail.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34098
      • Istanbul University- Cerrahpasa(IUC)
      • Contact: Merve Tugba Ozfidan Donmez, MD; Phone Number: 00905056444156; Email: mtozfidann@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FIVE Scores	Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation	baseline, 12 hours intervals, up to an hour of ICU discharge
Change in GKS Scores	Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation	baseline, 12 hours intervals, up to an hour of ICU discharge
Modified Rankin Scale	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	six months after ICU discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in ICU	Length of neuro ICU follow-up period	From hospitalization to hospital discharge, estimated average = 10 days
Length of stay in hospital	Length of hospital follow-up period	From hospitalization to hospital discharge, estimated average = 10 days

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: 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)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): January 25, 2024
• Study Completion (Estimated): February 25, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: GCS; Neuro-ICU; FIVE Score; FOUR Score; Modified Rankin Score
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Congenital Abnormalities; Craniocerebral Trauma; Trauma, Nervous System; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Malformations; Consciousness Disorders; Epilepsy; Neural Tube Defects; Epilepsies, Partial; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Nervous System Diseases; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Unconsciousness; Hematoma; Epilepsy, Temporal Lobe; Supratentorial Neoplasms; Arnold-Chiari Malformation; Infratentorial Neoplasms
• Other Study ID Numbers: E-72109855-604.01.01-7591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No