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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991157
• Other study ID #: 12.02
• Status: Completed
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Drug:
• Nimodipine

Locations

Country	Name	City	State
India	NIMHANS	Bengaluru

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the cardiac output measured using near NICOM technology 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
Secondary	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