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Optic Nerve Ultrasound in Severe Traumatic Injury (ONUS-TBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618226
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : June 1, 2020
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Venkatakrishna Rajajee, University of Michigan

Brief Summary:
Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring as the reference standard.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Device: Optic nerve ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Optic Nerve Ultrasound for the Detection of Intracranial Hypertension and Prediction of Therapeutic Intensity Level and Mortality Following Severe Traumatic Brain Injury (ONUS-TBI): a Prospective Blinded Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Optic nerve ultrasound
Optic nerve sheath diameter (ONSD) measurement will be performed in subjects with concomitant measurement of Intracranial Pressure (ICP) from an invasive ICP monitor. The operator measuring ONSD will be blinded to concomitant ICP.
Device: Optic nerve ultrasound
Measurement of ONSD with concomitant invasive ICP measurement will be performed at enrollment and at least daily for a total of 7 days. Additional measurements of ONSD may be performed at any time following any decline in Glasgow Coma Scale (GCS) score by 2+ points during the 7 day period.




Primary Outcome Measures :
  1. Intracranial Pressure (ICP) >25mmHg [ Time Frame: Days 1-7 ]
    Accuracy of ONSD measurement (index test) compared to the reference standard- ICP>25mmHg on concomitant invasive monitoring


Secondary Outcome Measures :
  1. Therapeutic Intensity Level (TIL) [ Time Frame: Assessed at time of discharge from the neurotrauma intensive care unit- Average expected to be about 7 days ]
    Highest Therapeutic Intensity Level attained during the ICU admission

  2. In-Hospital Mortality [ Time Frame: At Discharge from inpatient admission- Average expected to be about 30 days ]
    All-cause mortality during the inpatient admission

  3. Poor functional outcome at discharge- Glasgow Outcome Scale <4 [ Time Frame: At Discharge from inpatient admission- Average expected to be about 30 days ]
    Moderate or low disability at the time of discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (age>18 years) patients
  2. Severe TBI (GCS<8)
  3. First measurement feasible <48 hours from time of injury
  4. Clinical decision has been made to place an invasive ICP monitor, based on the recommendations of the Brain Trauma Foundation.

I. GCS<8 and Abnormal CT brain OR II. GCS<8 and Normal CT brain PLUS any 2 of the following

  1. Age>40
  2. Systolic blood pressure<90
  3. Unilateral or Bilateral Posturing

Exclusion Criteria:

  1. Patient not expected to survive >48 hours from the time of enrollment
  2. Known injury to the globe of the eye or the optic nerve
  3. Therapeutic Intensity Level 3 or 4 attained before ONSD measurement can be performed.

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): NCT02618226


Locations
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India
All India Institute of Medical Sciences (AIIMS)
New Delhi, India
Sponsors and Collaborators
University of Michigan
All India Institute of Medical Sciences, New Delhi
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Venkatakrishna (Krishna) Rajajee, MD University of Michigan
Additional Information:
Publications:

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Responsible Party: Venkatakrishna Rajajee, Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care, University of Michigan
ClinicalTrials.gov Identifier: NCT02618226    
Other Study ID Numbers: HUM00092614
IEC/NP-407/14.11.2014, RP ( Other Identifier: All India Institute of Medical Sciences (AIIMS) )
R03EB019352 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Venkatakrishna Rajajee, University of Michigan:
Traumatic Brain Injury
TBI
Optic nerve ultrasound
ONUS
Intracranial pressure
ICP
Intracranial hypertension
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Hypertension
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System