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IMMPRES: Intraoperative Monitoring & Management to Reduce Stroke

NCT04543838 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-11-08

Study results available
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Summary

The objective of this study is to prospectively evaluate the therapeutic effectiveness of with blood pressure management using intraoperative neurophysiological monitoring with SSEP and EEG to reduce perioperative stroke. The central hypothesis is that perioperative stroke occurs from emboli in the setting of significant hypoperfusion resulting in ischemia, which leads to infarction. The impact of the proposed research is that, if significant SSEP and EEG changes can be used to identify cerebral perfusion, then timely therapeutic interventions to effectively reduce the impact of perioperative stroke can be directed.

Conditions

  • Cardiac Surgery

Interventions

DIAGNOSTIC_TEST

Intervention

Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring

OTHER

Standard of Care BP management

If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented

Sponsors & Collaborators

  • Parthasarathy Thirumala

    lead OTHER

Principal Investigators

  • Parthasarathy Thirumala, MD, MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-01-17
Completion
2023-01-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543838 on ClinicalTrials.gov