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

March 23, 2019 updated by: Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bengaluru, India
        • NIMHANS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

aneurysmal subarachnoid hemorrhage with cerebral vasospasm

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the cardiac output measured using near NICOM technology after administration of nimodipine
Time Frame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
unit of measurement will be L/min
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
Time Frame: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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