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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Intracranial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NIMHANS

Bengaluru, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nimodipine

Drug

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

Time frame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine

unit of measurement will be L/min
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

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Dec 13, 2016
Registry last updated: Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed