NCT00151307

Brief Summary

The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological outcome, length of ICU stay, and length of hospital stay will be measured.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2 cardiovascular-diseases

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

First QC Date

September 6, 2005

Last Update Submit

June 5, 2008

Conditions

Cardiovascular DiseasesPostoperative Complications

Keywords

Heart surgeryCerebral oxygen saturationNeuropsychological function

Outcome Measures

Primary Outcomes (6)

  • Neuropsychological Outcome

  • Tests:

  • Anti-saccadic eye movement

  • Mini-mental state examination

  • Neurological testing

  • Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

Secondary Outcomes (3)

  • ICU & Hospital length of stay

  • Morbidity (complications post-op)

  • Mortality

Interventions

INVOS cerebral oximeterDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient
  • Elective cardiac surgery with cardiopulmonary bypass
  • Coronary artery disease or valvular heart disease or combination of both
  • Ability and willingness to give informed consent

You may not qualify if:

  • Pediatric patients
  • Emergency surgery
  • Unable to understand English
  • Allergic to tape used to attach oxygen sensor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital, Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

  • Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.

    PMID: 15578464BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fun-Sun Yao, M.D.

    Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2001

Study Completion

April 1, 2007

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

US(1)