NCT03969836

Brief Summary

Study of Regional Cerebral Oxygenation and Brain Blood Volume changes during Cardiac Surgery using the NeurOS system

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

May 28, 2019

Last Update Submit

February 13, 2024

Conditions

Heart Diseases

Keywords

cardiac surgery cerebral oxygenation, brain blood volumecerebral oxygenationbrain blood volume

Outcome Measures

Primary Outcomes (1)

  • Cerebral oxygenation readings from INVOS and NeurOS

    Cerebral oxygenation readings from INVOS and NeurOS

    From the beginning of surgery to skin closure

Secondary Outcomes (2)

  • NeurOS brain blood volume

    From the beginning of surgery to skin closure

  • 30 day mortality

    within 30 days of surgery

Study Arms (1)

NeurOS Group

All patients will have both INVOS and NeurOS systems placed before and during cardiac surgery for monitoring cerebral oxygenation and brain blood volume.

Device: NeurOS system

Interventions

NeurOS systemDEVICE

NeurOS system pads will be placed on patients' head for monitoring.

NeurOS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cardiac surgery patients

You may qualify if:

  • Having cardiac surgery at Jewish Hospital, Louisville, KY
  • Agree to research protocol
  • No allergy to either NeurOS or INOVS pads

You may not qualify if:

  • Refusal to participate
  • Emergency surgery
  • Intubated and ventilated before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Jiapeng Huang, MD, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 31, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)