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Clinical Trials/NCT02991157
NCT02991157
Completed
N/A

Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases

National Institute of Mental Health and Neuro Sciences, India1 site in 1 country25 target enrollmentDecember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage, Aneurysmal
Sponsor
National Institute of Mental Health and Neuro Sciences, India
Enrollment
25
Locations
1
Primary Endpoint
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute of Mental Health and Neuro Sciences, India
Responsible Party
Principal Investigator
Principal Investigator

Sriganesh Kamath

Associate Professor

National Institute of Mental Health and Neuro Sciences, India

Eligibility Criteria

Inclusion Criteria

  • aneurysmal subarachnoid hemorrhage
  • potential or actual cerebral vasospasm

Exclusion Criteria

  • non-aneurysmal subarachnoid hemorrhage
  • outside the 4-21 day window after ictus
  • peripheral deoxygenation
  • contraindication for nimodipine administration

Outcomes

Primary Outcomes

Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine

Time Frame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine

Secondary Outcomes

  • Change in the cardiac output measured using near NICOM technology after administration of nimodipine(Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine)
  • Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine(Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine)

Study Sites (1)

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