Clinical trial NCT06703619: Comparison Between GCS and FOUR Scores
Official title: A Comparison of Full Outline of Unresponsiveness Score With Glasgow Coma Scale Score in Predicting Outcomes Among Patients With Altered Mental Status Admitted to the Emergency Room
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coma
Keywords: GCS
FOUR score
COMA
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients (aged 18 years and above) presenting to the emergency room with altered mental status due to various underlying conditions, such as traumatic brain injury, metabolic encephalopathy, stroke, or central nervous system infections.

Participants will be selected from a tertiary care hospital emergency room where comprehensive medical and neurological assessments are routinely conducted. This population is expected to represent a diverse range of clinical presentations and severities of altered consciousness, making it suitable for evaluating the predictive performance of the Full Outline of Unresponsiveness (FOUR) score and the Glasgow Coma Scale (GCS).

Brief summary: The goal of this observational study is to compare the predictive utility of the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score in determining outcomes among patients with altered mental status admitted to the emergency room. The main questions it aims to answer are:

Does the FOUR Score provide a more accurate prediction of patient outcomes than the GCS Score? Are there specific patient subgroups where one score is more effective than the other?

Participants will:

Undergo assessment of mental status using both the FOUR Score and the GCS Score during their emergency room admission.

Have their clinical outcomes monitored during their hospital stay.

Detailed description: The Glasgow Coma Scale (GCS) is commonly used for neurological assessment, but it lacks the precision to cover the full range of consciousness changes.\[1\]

The GCS is a 15-point scale used to assess consciousness based on three components:

Eye Opening (E):

Spontaneous (4 points) To verbal command (3 points) To pain (2 points) No response (1 point)

Verbal Response (V):

Oriented (5 points) Confused (4 points) Inappropriate words (3 points) Incomprehensible sounds (2 points) No response (1 point)

Motor Response (M):

Obeys commands (6 points) Localizes pain (5 points) Withdrawal to pain (4 points) Abnormal flexion (decorticate posture, 3 points) Abnormal extension (decerebrate posture, 2 points) No response (1 point)

Scoring Range:

15 (best) to 3 (worst). A score ≤8 typically indicates severe brain injury. The Glasgow Coma Scale (GCS) cannot be applied to intubated or aphasic patients because their verbal responses cannot be assessed. Additionally, a withdrawal response to pain can easily be mistaken for a flexion response to pain. While eye-opening indicates wakefulness, it does not necessarily mean that the content of consciousness is intact, as seen in a persistent vegetative state. Furthermore, the GCS does not take into account important factors such as brainstem reflexes, changes in breathing patterns, or the need for mechanical ventilation, all of which could provide a clearer understanding of the coma's severity and offer a more comprehensive neurological assessment.\[1-3\]

Considering the limitations of the GCS, a new coma scale named the full outline of unresponsiveness (FOUR) score.\[2\] The scale has been designed to overcome the limitations mentioned above of GCS.

The FOUR score \[2\] completes it here as it has a higher neurological sophistication. The score is a 16-point scale consisting of four components: eye response, motor response, brainstem reflexes, and respiration.

Eye Response (E):

Eyelids open and tracking (4 points) Eyelids open but not tracking (3 points) Eyelids closed but open to loud voice (2 points) Eyelids closed and open only to pain (1 point) Eyelids closed with no response (0 points)

Motor Response (M):

Obeys commands (4 points) Localizes pain (3 points) Flexion to pain (2 points) Extension to pain (1 point) No response to pain (0 points)

Brainstem Reflexes (B):

Pupillary and corneal reflexes present (4 points) One reflex absent (3 points) Both reflexes absent (2 points) Pupillary reflex absent but corneal reflex present (1 point) No brainstem reflexes (0 points)

Respiration (R):

Not intubated, regular breathing (4 points) Not intubated, Cheyne-Stokes breathing (3 points) Not intubated, irregular breathing (2 points) Intubated and breathing above the ventilator rate (1 point) Intubated and apneic (0 points)

Scoring Range:

16 (best) to 0 (worst).

It can identify states of consciousness other than those approximated by GCS, such as vegetative state and locked-in state. It gives information in regard to respiratory drive and pattern and, therefore, can signal the necessity of mechanical ventilation in the comatose patient. It is more neurologically detailed by featuring brainstem reflexes and respiration components added to the test. It can also categorise the extent of the lowest value to three of the GCS. Hence, it is a more broad-based neurological exam that seems to have better potential to impact early definitive and triage.

Common clinical parameters used for evaluation and management in patients with altered mental status in the Iraqi setting are primarily focused on the use of the Glasgow Coma Scale (GCS) Score, which has been established to be of limited value in evaluating more complex neurological conditions. The Full Outline of Unresponsiveness (FOUR) Score has been proposed internationally as a more comprehensive tool, but its use and validation in the Iraqi population are relatively scarce. This absence of local studies on the comparison between the two scoring systems becomes a major concern as emergency patients may be at risk of the ways coaches devise strategies. The purpose of this study is to fill this gap by investigating and comparing the prognostic abilities of the FOUR Score and the GCS Score in Iraqi Emergency Room patients. Thus, the study aims at presenting information that may help decide when to implement better assessment tools that would ultimately improve patient care for those with the altered mental status.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the emergency room with altered mental status.
* Patients were assessed using both the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score upon admission.
* Patients whose clinical outcomes (e.g., mortality, length of hospital stay, need for intensive care) are available for follow-up and analysis.

Exclusion Criteria:

* Patients with incomplete or missing data on FOUR and/or GCS assessments.
* Patients who leave against medical advice (LAMA) or are discharged before outcome data can be collected.
* Patients with pre-existing neurological conditions that might independently influence outcomes (e.g., severe dementia, long-standing neurodegenerative diseases).
* Patients in whom resuscitative measures were initiated but unsuccessful before scoring could be performed.

Primary outcomes:
measure: In hospital mortality
timeFrame: average of 10 days through discharge
measure: Accuracy Assessment of the Glasgow Coma Scale (GCS)
timeFrame: the first 12 hours after ER admission
measure: Accuracy Assessment of the Full Outline of UnResponsiveness (FOUR) Score
timeFrame: the first 12 hours after ER admission
Secondary outcomes:
measure: Length of Hospitalization
timeFrame: average of 10 days through discharge
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Medicine - Al-Nahrain University
Study officials:
affiliation: College Of Medicine - Nahrain University
name: Hasan Azeez Al-Hamadani, Professor of Neurology
role: STUDY_CHAIR
References:
citation: Fischer M, Ruegg S, Czaplinski A, Strohmeier M, Lehmann A, Tschan F, Hunziker PR, Marsch SC. Inter-rater reliability of the Full Outline of UnResponsiveness score and the Glasgow Coma Scale in critically ill patients: a prospective observational study. Crit Care. 2010;14(2):R64. doi: 10.1186/cc8963. Epub 2010 Apr 14.
citation: Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.
citation: Segatore M, Way C. The Glasgow Coma Scale: time for change. Heart Lung. 1992 Nov-Dec;21(6):548-57.