ComaGCS/FOURNCT06703619
Comparison Between GCS and FOUR Scores
An observational study of Coma, run by Al-Nahrain University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma
- How many people
- 240 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2024to 3 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Full Outline of UnResponsiveness (FOUR) Score and Glasgow Coma Scale in Predicting Clinical Outcomes in Patients With Altered Mental Status Presenting to the Emergency Department: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Coma
- Keywords
- GCS, FOUR score, COMA
- Medical subject headings
- Coma
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
Mortality (death) during hospitalization
Measured: average of 10 days through discharge
Accuracy Assessment of the Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS): Range 3-15; higher scores indicate better neurological status.
Measured: the first 12 hours after ER admission
Accuracy Assessment of the Full Outline of UnResponsiveness (FOUR) Score
Full Outline of Unresponsiveness (FOUR) score: Range 0-16; higher scores indicate better neurological status.
Measured: the first 12 hours after ER admission
Secondary outcomes (1)
Length of Hospitalization
The total duration of a patient's stay in the hospital, measured from the date of admission to the date of discharge. This includes all days spent in general wards, intensive care units (ICU), and other hospital departments as part of their treatment course.
Measured: average of 10 days through discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 May 2024
- Primary completion1 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul-Ilah R. Khamis, Al-Nahrain University
- Investigators
- Hasan Azeez Al-Hamadani, Professor of Neurology, Study chair, College Of Medicine - Nahrain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703619
- Sponsor's protocol ID
- UNCOMIRB20240520
- Acronym
- GCS/FOUR
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20398274Wijdicks 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.
PubMed 16178024Segatore M, Way C. The Glasgow Coma Scale: time for change. Heart Lung. 1992 Nov-Dec;21(6):548-57.
PubMed 1447002
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Full Outline of UnResponsiveness (FOUR) Score and Glasgow Coma Scale in Predicting Clinical Outcomes in Patients With Altered Mental Status Presenting to the Emergency Department: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06703619
- Acronym / sponsor ID
- GCS/FOUR / UNCOMIRB20240520
- Conditions
- Coma
- Keywords
- GCS, FOUR score, COMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In hospital mortality
Time frame: average of 10 days through discharge
Mortality (death) during hospitalization
Accuracy Assessment of the Glasgow Coma Scale (GCS)
Time frame: the first 12 hours after ER admission
Glasgow Coma Scale (GCS): Range 3-15; higher scores indicate better neurological status.
Accuracy Assessment of the Full Outline of UnResponsiveness (FOUR) Score
Time frame: the first 12 hours after ER admission
Full Outline of Unresponsiveness (FOUR) score: Range 0-16; higher scores indicate better neurological status.
1 secondary outcome
Length of Hospitalization
Time frame: average of 10 days through discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Results publication: PubMed 20398274Fischer 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.
- Results publication: PubMed 16178024Wijdicks 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.
- Results publication: PubMed 1447002Segatore M, Way C. The Glasgow Coma Scale: time for change. Heart Lung. 1992 Nov-Dec;21(6):548-57.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Azeez Al-Hamadani, Professor of Neurology study chair
College Of Medicine - Nahrain University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma, run by Al-Nahrain University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: average of 10 days through discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703619, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.