Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2014 |
| End Date: | September 2017 |
| Contact: | Michael Fahr, MD, FACS |
| Email: | Michael.Fahr@ololrmc.com |
| Phone: | (225) 765-8371 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
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