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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06036732
• Other study ID #: E-72109855-604.01.01-7591
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Merve Tugba Ozfidan Donmez, MD
• Phone: 00905056444156
• Email: mtozfidann[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 223
• Est. completion date: February 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arnold Chiari Malformation
• Arnold-Chiari Malformation
• Assessment, Self
• Brain Injuries
• Brain Injuries, Traumatic
• Coma
• Epilepsy, Temporal Lobe
• Hematoma
• Hemorrhage
• Infratentorial Neoplasms
• Intensive Care Neurological Disorder
• Intracranial Hemorrhages
• Nervous System Diseases
• Subarachnoid Hemorrhage
• Supratentorial Neoplasms
• Traumatic Brain Injury
• Unconsciousness

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa(IUC)	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay in ICU	Length of neuro ICU follow-up period	From hospitalization to hospital discharge, estimated average = 10 days
Other	Length of stay in hospital	Length of hospital follow-up period	From hospitalization to hospital discharge, estimated average = 10 days
Primary	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
Primary	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
Primary	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