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Optic Nerve Ultrasound in Severe Traumatic Injury

NCT02618226 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2021-01-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Venkatakrishna (Krishna) Rajajee, MD · University of Michigan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • India

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02618226 on ClinicalTrials.gov