NCT00745394

Brief Summary

Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in widespread use in the clinical care of pediatric cardiac patients in the operating room and in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on the forehead or lower back, blood oxygen concentration data is obtained which has been found to correlate with actual blood samples taken by IV. The presence of this NIRS data would give the surgeon important feedback about blood flow to important areas like the brain and kidneys during heart surgeries on children and after the operation is completed in the intensive care unit. The investigator wishes to perform a prospective study of the NIRS monitor use with children that need heart surgeries that require heart-lung bypass and sometimes require monitoring in the ICU, post-operatively.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2008

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

August 29, 2008

Last Update Submit

January 21, 2025

Conditions

Cardiopulmonary Bypass

Keywords

NIRSbypasscardiopulmonaryCPBmonitoringsystem

Outcome Measures

Primary Outcomes (1)

  • Determine correlation between cerebral/somatic NIRS saturation data obtained on CPB and oxygen saturation and lactate data obtained from the superior vena caval (SVC) blood.

    Length of surgery with possible 5 day follow-up in the ICU

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children who undergo surgical correction of their congenital heart disease that require cardiopulmonary bypass.

You may qualify if:

  • \. Patients that require cardiopulmonary bypass during surgical correction of heart disease
  • \. Prospective, Informed Consent

You may not qualify if:

  • \. Patients with malformations of venous return to the heart (e.g. interrupted IVC with azygous continuation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Study Officials

  • Joseph Forbess, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 3, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

December 31, 2008

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

US(1)