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

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

Sponsors

Lead sponsor: National Institute of Mental Health and Neuro Sciences, India

Source National Institute of Mental Health and Neuro Sciences, India
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.

Overall Status Completed
Start Date December 2016
Completion Date December 2018
Primary Completion Date November 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
Secondary Outcome
Measure Time Frame
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
Enrollment 25
Condition
Intervention

Intervention type: Drug

Intervention name: Nimodipine

Eligibility

Sampling method: Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Location
facility
NIMHANS
Location Countries

India

Verification Date

March 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: National Institute of Mental Health and Neuro Sciences, India

Investigator full name: Sriganesh Kamath

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov