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Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02465242
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.


Condition or disease
Traumatic Brain Injury

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

Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. FIM + FAM at 30, 60, and 90 days post injury [ Time Frame: 30, 60, and 90 days post injury ]
  5. Activities of daily living (ADL) [ Time Frame: 90 days post injury ]
  6. Quality of Life (QoL) [ Time Frame: 90 days post-injury ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult trauma patients age 18 years or older with evidence of traumatic brain injury and intubated requiring mechanical ventilation.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465242


Contacts
Contact: Danielle Tatum, Ph.D. (225) 765-6649 Danielle.Tatum@ololrmc.com
Contact: Hollis O'Neal, MD, MSc (225) 757-4070 honeal@lsuhsc.edu

Locations
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Danielle Tatum, Ph.D.    225-765-6649    Danielle.Tatum@ololrmc.com   
Contact: Hollis O'Neal, MD, MSc    225-757-4070    honeal@lsuhsc.edu   
Sponsors and Collaborators
Our Lady of the Lake Regional Medical Center
Investigators
Principal Investigator: Danielle Tatum, Ph.D. Our Lady of the Lake Regional Medical Center
More Information

Responsible Party: Danielle Tatum, Academic Research Director, Our Lady of the Lake Regional Medical Center
ClinicalTrials.gov Identifier: NCT02465242     History of Changes
Other Study ID Numbers: #8657
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System