Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00883922
First received: April 17, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

Children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. Part of the routine care at UCLA includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. However, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children.

The purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors during a heart surgery. This is an observational study and the patients will not undergo any research specific procedures in the operating room (OR). The investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. This study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. The investigators will also observe the same parameters in the ICU. The investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.


Condition
Congenital Heart Defects
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Estimated Enrollment: 100
Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for cardiac surgery

Criteria

Inclusion Criteria:

  • Pediatric patients (age 0-12 years) scheduled for cardiac surgery and requiring placement of a central venous catheter.

Exclusion Criteria:

  • Patients with contraindications for placement of a central venous catheter will be excluded from this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883922

Contacts
Contact: Jennifer Corniea, MA 310-206-4484 jcorniea@mednet.ucla.edu
Contact: Aman Mahajan, MD, PhD 310-267-8680 amahajan@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jennifer Corniea, MA    310-206-4484    jcorniea@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Aman Mahajan, MD, PhD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT00883922     History of Changes
Other Study ID Numbers: 06-12-078-03
Study First Received: April 17, 2009
Last Updated: April 17, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 24, 2014