NCT02426268

Brief Summary

The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Longer than P75 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

May 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

5.1 years

First QC Date

April 21, 2015

Last Update Submit

November 2, 2020

Conditions

Cardiac Surgical Patients

Keywords

cardiac surgerycerebral oximetrylower extremity oximetry

Outcome Measures

Primary Outcomes (1)

  • Cerebral Oxygen Saturation

    Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation.

    Duration of the surgery (~5-7 hours)

Secondary Outcomes (1)

  • Non-Cerebral Oxygen Saturation

    Duration of the surgery (~5-7 hours)

Eligibility Criteria

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

Cardiothoracic surgical population at UCLA

You may qualify if:

  • Subjects where cerebral oximetry is monitored during their surgery

You may not qualify if:

  • Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Los Angeles, California, 90095, United States

Location

Study Officials

  • Emily Methangkool, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

May 1, 2014

Primary Completion

June 6, 2019

Study Completion

November 21, 2019

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

US(1)