Traumatic Brain Injury (TBI) PatientsPUPILNCT07838350
Pupillometry in Critical Care
An observational study of Traumatic Brain Injury (TBI) Patients, run by Walton Centre NHS Foundation Trust.
Trial summary
Traumatic Brain Injury is a leading cause of death and disability in adults worldwide. The investigators want to find the best way to predict which patients with head injuries are going to deteriorate in order to get medical treatment promptly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2020to 6 Jun 2022
- 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
- Adult, Older adult
Study population: Eligible patients admitted to Neuro Critical Care Unit within 48 hours of head injury
Who may be able to join
- Patients with severe TBI only aged 18 years or older
- At least one reactive pupil on admission
- Validated and sedated in induced coma in the Neuro Critical Care Unit
Who cannot join
- Patients with a direct eye trauma, as well as any with a medical history that could impact the relevance of eye examination (opalescent cataract, iris surgery, blindness, third intracranial nerve direct damage) will be excluded.
- Patients with irreversible signs of coma at admission (bilateral and nonreactive dilated pupils) will be excluded.
- Patients receiving drugs such as barbiturates, that are known to alter pupil reactivity, will be recorded but excluded from ICP association data.
About this study
Official title: Validity of Quantitative Pupillometry in Neurocritical Care and Correlation With Intracranial Pressure : an Observational, Uni-institutional Study
Traumatic Brain Injury is a leading cause of death and disability in adults worldwide. The investigators want to find the best way to predict which patients with head injuries are going to deteriorate in order to get medical treatment promptly. Pupil examination is an essential part of a neurological assessment, providing a window in to the brain. Abnormalities in measurement of pupil size and response to light indicates rising pressure inside the rigid skull (intracranial pressure (ICP)), which results in significant death and disability.
Read the detailed description
Traumatic brain injury (TBI) is a leading cause of death and disability in adults worldwide. Severe TBI, defined as a Glasgow Coma Score (GCS) 8, is associated with mortality as high as 30-40%. It is established that the major determinant of outcome following TBI and target of medical interventions is secondary brain injury, primarily cerebral ischaemia. It is due to a combination of intracranial hypertension (ICH), systemic hypotension, hypoxia, hyperpyrexia, hypercapnia and hypoglycaemia, all have been shown to independently worsen survival after TBI. ICH refers to rise in pressure inside the rigid skull (intracranial pressure (ICP)), which reduces blood flow and oxygen to the brain. ICP values over 20-25mmHg are indicative of ICH. Accordingly, treatment of these patients centres on controlling ICP, improving cerebral blood flow (CBF) and oxygenation.
Monitoring pupil size and its light reflex mechanism is an integral part of non-invasive clinical monitoring in patients with severe brain injury in NCCUs globally. Abnormalities in pupillary response or size asymmetry are associated with neurological deterioration and poor outcome. In addition, studies have shown a strong correlation with brainstem oxygenation and blood flow.
A study evaluating pupil response and ICP showed that changes in pupils were detected even in patients with normal ICP. Crucially, they suggested that abnormalities in posterior frontal and temporal regions of the brain may occur even when the ICP is normal. Given the indispensable role of these parameters, there is considerable impetus to ensure they are measured accurately.
The invetigator's study aims to compare the use of standard pen torch versus quantitative pupillometer for pupil assessment in severely brain injured patients in NCCU. This data could establish whether currently practised pen torch assessment is inadequate for clinical practice. The investigators also propose to study whether pupil response (NPi) changes with rising ICP. This group of patients have invasive monitoring in place as standard care and provides an important opportunity to study this relationship. This has the potential to allow early, non-invasive detection of neurological deterioration and as such, indication for timely intervention in the first instance. It also allows scope for development of this tool across emergency departments and even pre-hospital care settings.
The primary aims of this study are twofold. First, to compare the accuracy and reliability of the pupillometer device (NPi 200) versus the conventional pen-torch technique in measuring pupil response in patients with severe TBI in NCCU.
Second, to evaluate the relationship between the important measures of neurological deterioration in TBI patients: ICP, CPP, and NPi. This will be achieved by simultaneous recording of NPi and ICP (a standard invasive clinical monitoring tool) to assess for any correlation. The investigator will also be noting the measurement displayed by the ICP monitor at the time of pupil measurement or conversely note the NPi at the time of any significant ICP rise.
This observational study will recruit patients who are admitted to NCCU within 48 hours of brain injury. The end point of the study will be when ICP monitors are removed which is normally 7-10 days, unless the patient recovers earlier or passes away. Data collection will cease in periods requiring surgical treatment. Patient recruitment will cease after 6 months
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Keywords
- Traumatic brain injury, Pupillometry, Critical Care
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Hourly Pupil response
Measured: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers
Hourly NPi Value and corresponding ICP value
Measured: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start7 Jan 2020
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine McMahon, Principal investigator, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838350
- Sponsor's protocol ID
- RG297-19
- Acronym
- PUPIL
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Quantitative Pupillometry in Neurocritical Care and Correlation With Intracranial Pressure : an Observational, Uni-institutional Study
- ClinicalTrials.gov ID
- NCT07838350
- Acronym / sponsor ID
- PUPIL / RG297-19
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Keywords
- Traumatic brain injury, Pupillometry, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 24 Sep 2026 (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.
Traumatic Brain Injury is a leading cause of death and disability in adults worldwide. The investigators want to find the best way to predict which patients with head injuries are going to deteriorate in order to get medical treatment promptly. Pupil examination is an essential part of a neurological assessment, providing a window in to the brain. Abnormalities in measurement of pupil size and response to light indicates rising pressure inside the rigid skull (intracranial pressure (ICP)), which results in significant death and disability.
Detailed description
Traumatic brain injury (TBI) is a leading cause of death and disability in adults worldwide. Severe TBI, defined as a Glasgow Coma Score (GCS) 8, is associated with mortality as high as 30-40%. It is established that the major determinant of outcome following TBI and target of medical interventions is secondary brain injury, primarily cerebral ischaemia. It is due to a combination of intracranial hypertension (ICH), systemic hypotension, hypoxia, hyperpyrexia, hypercapnia and hypoglycaemia, all have been shown to independently worsen survival after TBI. ICH refers to rise in pressure inside the rigid skull (intracranial pressure (ICP)), which reduces blood flow and oxygen to the brain. ICP values over 20-25mmHg are indicative of ICH. Accordingly, treatment of these patients centres on controlling ICP, improving cerebral blood flow (CBF) and oxygenation.
Monitoring pupil size and its light reflex mechanism is an integral part of non-invasive clinical monitoring in patients with severe brain injury in NCCUs globally. Abnormalities in pupillary response or size asymmetry are associated with neurological deterioration and poor outcome. In addition, studies have shown a strong correlation with brainstem oxygenation and blood flow.
A study evaluating pupil response and ICP showed that changes in pupils were detected even in patients with normal ICP. Crucially, they suggested that abnormalities in posterior frontal and temporal regions of the brain may occur even when the ICP is normal. Given the indispensable role of these parameters, there is considerable impetus to ensure they are measured accurately.
The invetigator's study aims to compare the use of standard pen torch versus quantitative pupillometer for pupil assessment in severely brain injured patients in NCCU. This data could establish whether currently practised pen torch assessment is inadequate for clinical practice. The investigators also propose to study whether pupil response (NPi) changes with rising ICP. This group of patients have invasive monitoring in place as standard care and provides an important opportunity to study this relationship. This has the potential to allow early, non-invasive detection of neurological deterioration and as such, indication for timely intervention in the first instance. It also allows scope for development of this tool across emergency departments and even pre-hospital care settings.
The primary aims of this study are twofold. First, to compare the accuracy and reliability of the pupillometer device (NPi 200) versus the conventional pen-torch technique in measuring pupil response in patients with severe TBI in NCCU.
Second, to evaluate the relationship between the important measures of neurological deterioration in TBI patients: ICP, CPP, and NPi. This will be achieved by simultaneous recording of NPi and ICP (a standard invasive clinical monitoring tool) to assess for any correlation. The investigator will also be noting the measurement displayed by the ICP monitor at the time of pupil measurement or conversely note the NPi at the time of any significant ICP rise.
This observational study will recruit patients who are admitted to NCCU within 48 hours of brain injury. The end point of the study will be when ICP monitors are removed which is normally 7-10 days, unless the patient recovers earlier or passes away. Data collection will cease in periods requiring surgical treatment. Patient recruitment will cease after 6 months
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible patients admitted to Neuro Critical Care Unit within 48 hours of head injury
Key inclusion criteria (3 listed)
- Patients with severe TBI only aged 18 years or older
- At least one reactive pupil on admission
- Validated and sedated in induced coma in the Neuro Critical Care Unit
Key exclusion criteria (3 listed)
- Patients with a direct eye trauma, as well as any with a medical history that could impact the relevance of eye examination (opalescent cataract, iris surgery, blindness, third intracranial nerve direct damage) will be excluded.
- Patients with irreversible signs of coma at admission (bilateral and nonreactive dilated pupils) will be excluded.
- Patients receiving drugs such as barbiturates, that are known to alter pupil reactivity, will be recorded but excluded from ICP association data.
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
Hourly Pupil response
Time frame: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers
Hourly NPi Value and corresponding ICP value
Time frame: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers
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 24 Sep 2026.
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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.
Catherine McMahon principal investigator
Walton Centre NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI) Patients, run by Walton Centre NHS Foundation Trust.
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 3 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Hourly Pupil response (time frame: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.