Traumatic Brain InjuryNCT02465242
Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Our Lady of the Lake Hospital at 1 site in United States.
Trial summary
Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC states that 1.7 million people sustain a traumatic brain injury each year, with death occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly require hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2017
- 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: Adult trauma patients age 18 years or older with evidence of traumatic brain injury and intubated requiring mechanical ventilation.
Who may be able to join
- Adult patients 18 years of age or older
- Presence of subdural hematoma (SDH), subarachnoid hemorrhage (SAH), epidural hematoma (EDH) or intracerebral hemorrhage (ICH), or cerebral contusion resultant from traumatic brain injury
- Intubated requiring mechanical ventilation
Who cannot join
- Unable to obtain initial pupillometer reading within six (6) hours of traumatic insult
- History of blindness or enucleation of one or both eyes
- Traumatic injury to one or both eyes such that pupillometry is not possible
- Previous history of known Third Cranial Nerve palsy
- Administration of IV or topical atropine within 6 hours of first pupillometer reading
- Unwilling or unable to consent (or unable to find an appropriate surrogate)
Show all 9Show fewer
- Pregnant
- History of severe dementia or neurodegenerative disease, mental illnesses requiring long-term institutionalization, severe neuromuscular disorders (Parkinson's disease, Huntington's disease), previous structural brain defect either congenital or due to previous trauma or medical disease, previous anoxic brain injury
- Expected death within 24 hours of enrollment, or desire by patient of family to pursue palliative rather than aggressive, supportive care
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Danielle Tatum, Ph.D., 225-765-6649, Danielle.Tatum@ololrmc.com
Hollis O'Neal, MD, MSc, 225-757-4070, honeal@lsuhsc.edu
About this study
Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC states that 1.7 million people sustain a traumatic brain injury each year, with death occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly require hospitalization. The costs of TBI can be devastating to our society, with the 2010 economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have high rates of institutionalization, readmission, and disability.
The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis evaluation in the acute phase of care varies widely among physicians caring for these patients[3]. With prognosis often in doubt, physicians have difficulty leading families and patients toward the most appropriate treatment which often leads to expensive testing and patient management. The Brain Trauma Foundation has recommended several early indicators of prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have been extensively studied, however accurate measurements of these prognostic factors have not been performed due to a lack of standardized measuring procedure.
A new device has been validated to measure both pupil size and reactivity using infrared pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi) as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial pressure readings, however there are no studies correlating the pupillometer findings with outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable predictor of 30-day outcomes in patients with severe TBI.
Read the detailed description
BACKGROUND Pupillary light reflexes have long been used as an important prognostic parameter for predicting outcome following severe TBI. Despite this long history, pupillary assessment remains an inexact science replete with subjectivity and high inter-rater variability. This highlights the need for a reliable, standardized, and accurate measuring procedure.
The NeurOptics NPi-100 Pupillometer is a handheld portable infrared device that allows for objective measurement of pupillary sizes and reflexes. This device utilizes an algorithm derived from multiple measurements taken automatically by the pupillometer to generate the NPi (Neurological Pupil Index). This index allows clinicians to reliably quantify the various aspects of pupillary response to a logical, quantitative scale. Similar devices have demonstrated improvements in both inter- and intra-observer reliability in the assessment of the pupillary response. Although pupillometry has been shown to be a reliable and early indicator of increased intracranial pressure, it is unclear if the results of pupillometry or the NPi can reliably predict functional outcomes in patients with traumatic brain injury.
STUDY OBJECTIVE This is a prospective study designed to determine if the pupillary reflex, as measured by pupillometry and quantified by the NPi, is a reliable prognosticator of both functional outcome and/or mortality in patients with TBI.
STUDY POPULATION The patients to be included in this study will be adults 18 years of age or older who present to the emergency department (ED) with a traumatic brain injury and who are intubated requiring mechanical ventilation.
STUDY PROCEDURES All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the ED as per standard evaluation of all trauma patients. Beyond that, pupillometry and reporting of the NPi will be performed every six (6) hours (Q4) by the bedside nurse throughout the patient's stay in the TNCC. For the long term follow-up phase, functional recovery [as determined by the Functional Independence Measure (FIM) and Functional Assessment Measure (FAM)], Activities of Daily Living (ADL), and Quality of Life (QoL) among the TBI survivors will be assessed when the patients are discharged from the hospital and/or rehabilitation facility. Functional recovery (FIM + FAM) will be assessed at discharge from the TNCC and at 30, 60, and 90 days post-injury. ADL and QoL will be assessed at 90 days post-injury. Vital status will be recorded at discharge from the TNCC and at 90 days post-injury.
POTENTIAL RISK All interventions are usual practice/standard of care within our institution. There is essentially no risk to our patients due to this study.
Because the investigators are maintaining identifiable information for long-term follow-up and assessment, the potential for loss of personal health information exists. To attenuate this risk, all identifiable information will be kept on a password-protected hospital computer in a locked office.
POTENTIAL BENEFIT There is little specific benefit to the individual subjects in this study other than contributing to the advancement of knowledge. A general benefit would be demonstrating the pupillometer to be a reliable predictor of functional outcome of TBI. This would better aid physicians in their prognosis evaluation in the acute phase of care and in deciding the most appropriate treatment for patients.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NPi greather than 3 | All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the emergency department as per standard evaluation of all trauma patients. If pupils are unequal, group assignment will be determined by lowest pupil reading. Patients with an NPi greater than 3 will be assigned to this group. Pupillometry readings will be gathered for the first 7 days of hospital admission or until discharge. 30, 60, and 90 day post-injury outcomes will be collected. | |
| NPi less than or equal to 3 | All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the emergency department as per standard evaluation of all trauma patients. If pupils are unequal, group assignment will be determined by lowest pupil reading. Patients with an NPi less than or equal to 3 will be assigned to this group. Pupillometry readings will be gathered for the first 7 days of hospital admission or until discharge. 30, 60, and 90 day post-injury outcomes will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure + Functional Assessment Measure (FIM + FAM)
The FIM/FAM is a single outcome measure. The FAM is an adjunct to the FIM and is not meant to stand alone as an assessment measure.
Measured: Time of discharge from ICU, which is typically a duration of 2-3 weeks
Secondary outcomes (6)
Survival
Measured: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
Time to discharge from acute care facility
Measured: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
Time to discharge to home
Measured: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
FIM + FAM at 30, 60, and 90 days post injury
Measured: 30, 60, and 90 days post injury
Activities of daily living (ADL)
Measured: 90 days post injury
Quality of Life (QoL)
Measured: 90 days post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Tatum, Our Lady of the Lake Hospital
- Investigators
- Danielle Tatum, Ph.D., Principal investigator, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465242
- Sponsor's protocol ID
- #8657
- Status last verified
- Sep 2016
- First submitted
- 1 Jun 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02465242
- Acronym / sponsor ID
- #8657
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- 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 (TBI) is a major cause of morbidity and mortality in the US. The CDC states that 1.7 million people sustain a traumatic brain injury each year, with death occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly require hospitalization. The costs of TBI can be devastating to our society, with the 2010 economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have high rates of institutionalization, readmission, and disability.
The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis evaluation in the acute phase of care varies widely among physicians caring for these patients[3]. With prognosis often in doubt, physicians have difficulty leading families and patients toward the most appropriate treatment which often leads to expensive testing and patient management. The Brain Trauma Foundation has recommended several early indicators of prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have been extensively studied, however accurate measurements of these prognostic factors have not been performed due to a lack of standardized measuring procedure.
A new device has been validated to measure both pupil size and reactivity using infrared pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi) as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial pressure readings, however there are no studies correlating the pupillometer findings with outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable predictor of 30-day outcomes in patients with severe TBI.
Detailed description
BACKGROUND Pupillary light reflexes have long been used as an important prognostic parameter for predicting outcome following severe TBI. Despite this long history, pupillary assessment remains an inexact science replete with subjectivity and high inter-rater variability. This highlights the need for a reliable, standardized, and accurate measuring procedure.
The NeurOptics NPi-100 Pupillometer is a handheld portable infrared device that allows for objective measurement of pupillary sizes and reflexes. This device utilizes an algorithm derived from multiple measurements taken automatically by the pupillometer to generate the NPi (Neurological Pupil Index). This index allows clinicians to reliably quantify the various aspects of pupillary response to a logical, quantitative scale. Similar devices have demonstrated improvements in both inter- and intra-observer reliability in the assessment of the pupillary response. Although pupillometry has been shown to be a reliable and early indicator of increased intracranial pressure, it is unclear if the results of pupillometry or the NPi can reliably predict functional outcomes in patients with traumatic brain injury.
STUDY OBJECTIVE This is a prospective study designed to determine if the pupillary reflex, as measured by pupillometry and quantified by the NPi, is a reliable prognosticator of both functional outcome and/or mortality in patients with TBI.
STUDY POPULATION The patients to be included in this study will be adults 18 years of age or older who present to the emergency department (ED) with a traumatic brain injury and who are intubated requiring mechanical ventilation.
STUDY PROCEDURES All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the ED as per standard evaluation of all trauma patients. Beyond that, pupillometry and reporting of the NPi will be performed every six (6) hours (Q4) by the bedside nurse throughout the patient's stay in the TNCC. For the long term follow-up phase, functional recovery [as determined by the Functional Independence Measure (FIM) and Functional Assessment Measure (FAM)], Activities of Daily Living (ADL), and Quality of Life (QoL) among the TBI survivors will be assessed when the patients are discharged from the hospital and/or rehabilitation facility. Functional recovery (FIM + FAM) will be assessed at discharge from the TNCC and at 30, 60, and 90 days post-injury. ADL and QoL will be assessed at 90 days post-injury. Vital status will be recorded at discharge from the TNCC and at 90 days post-injury.
POTENTIAL RISK All interventions are usual practice/standard of care within our institution. There is essentially no risk to our patients due to this study.
Because the investigators are maintaining identifiable information for long-term follow-up and assessment, the potential for loss of personal health information exists. To attenuate this risk, all identifiable information will be kept on a password-protected hospital computer in a locked office.
POTENTIAL BENEFIT There is little specific benefit to the individual subjects in this study other than contributing to the advancement of knowledge. A general benefit would be demonstrating the pupillometer to be a reliable predictor of functional outcome of TBI. This would better aid physicians in their prognosis evaluation in the acute phase of care and in deciding the most appropriate treatment for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPi greather than 3 | – | –All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the emergency department as per standard evaluation of all trauma patients. If pupils are unequal, group assignment will be determined by lowest pupil reading. Patients with an NPi greater than 3 will be assigned to this group. Pupillometry readings will be gathered for the first 7 days of hospital admission or until discharge. 30, 60, and 90 day post-injury outcomes will be collected. |
| NPi less than or equal to 3 | – | –All patients will undergo initial pupillometry evaluation with recording of the NPi in the initial evaluation in the emergency department as per standard evaluation of all trauma patients. If pupils are unequal, group assignment will be determined by lowest pupil reading. Patients with an NPi less than or equal to 3 will be assigned to this group. Pupillometry readings will be gathered for the first 7 days of hospital admission or until discharge. 30, 60, and 90 day post-injury outcomes will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult trauma patients age 18 years or older with evidence of traumatic brain injury and intubated requiring mechanical ventilation.
Key inclusion criteria (3 listed)
- Adult patients 18 years of age or older
- Presence of subdural hematoma (SDH), subarachnoid hemorrhage (SAH), epidural hematoma (EDH) or intracerebral hemorrhage (ICH), or cerebral contusion resultant from traumatic brain injury
- Intubated requiring mechanical ventilation
Key exclusion criteria (9 listed)
- Unable to obtain initial pupillometer reading within six (6) hours of traumatic insult
- History of blindness or enucleation of one or both eyes
- Traumatic injury to one or both eyes such that pupillometry is not possible
- Previous history of known Third Cranial Nerve palsy
- Administration of IV or topical atropine within 6 hours of first pupillometer reading
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
Functional Independence Measure + Functional Assessment Measure (FIM + FAM)
Time frame: Time of discharge from ICU, which is typically a duration of 2-3 weeks
The FIM/FAM is a single outcome measure. The FAM is an adjunct to the FIM and is not meant to stand alone as an assessment measure.
6 secondary outcomes
Survival
Time frame: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
Time to discharge from acute care facility
Time frame: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
Time to discharge to home
Time frame: Patients will be followed for duration of hospital stay, typically a duration of 2-3 weeks, but potentially longer in the case of more severe cases
FIM + FAM at 30, 60, and 90 days post injury
Time frame: 30, 60, and 90 days post injury
Activities of daily living (ADL)
Time frame: 90 days post injury
Quality of Life (QoL)
Time frame: 90 days post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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.
Danielle Tatum, Ph.D. principal investigator
Our Lady of the Lake Hospital
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 Traumatic Brain Injury, run by Our Lady of the Lake Hospital at 1 site in United States.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2016. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Tatum, Ph.D. ((225) 765-6649, Danielle.Tatum@ololrmc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure + Functional Assessment Measure (FIM + FAM) (time frame: Time of discharge from ICU, which is typically a duration of 2-3 weeks). 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 28 Sep 2016.