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Clinical Trials/CTRI/2019/07/020170
CTRI/2019/07/020170
Not yet recruiting
Phase 3

EFFECT OF RESPIRATORY PHYSIOLOGICAL CHANGES ON INTRACRANIAL PHYSIOLOGY; OPTIC NERVE SHEATH DIAMETER (ONSD) AND CEREBRAL OXYGEN SATURATION (rScO2) IN ACUTE TRAUMATIC BRAIN INJURY (TBI)

ational Institute of Mental Health and Neurosciences0 sites0 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
ational Institute of Mental Health and Neurosciences
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
ational Institute of Mental Health and Neurosciences

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • Patients admitted to ICU \< 72 hrs of acute TBI
  • Patients with baseline requirements of FiO2 \<\= 50% and PEEP \<\= 5 cm H2O
  • Haemodynamic stability
  • Focal lesion in the brain

Exclusion Criteria

  • Age \<\= 18 years
  • Patients with supra\-normal requirements of FiO2 and PEEP
  • Patients with ophthalmological conditions (glaucoma or eye trauma)
  • Conditions where rScO2 measurement using NIRS may be unreliable
  • Conditions with persistent midline shift more than pre\-op status
  • Baseline ONSD \> 6 mm
  • Baseline rScO2 \< 50%

Outcomes

Primary Outcomes

Not specified

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