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

NCT02465242 | Unknown

• 1 other identifier: #8657
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Time of discharge from ICU, which is typically a duration of 2-3 weeks

Secondary Outcomes (6)

• Survival

  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

  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

  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

  30, 60, and 90 days post injury

• Activities of daily living (ADL)

  90 days post injury

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Danielle Tatum, Ph.D.

  Our Lady of the Lake Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Tatum, Ph.D.

CONTACT

(225) 765-6649; Danielle.Tatum@ololrmc.com

Hollis O'Neal, MD, MSc

CONTACT

(225) 757-4070; honeal@lsuhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Director

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)