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

NCT00883922 | Completed

• 1 other identifier: 06-12-078-03
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Defects; Cardiac Surgery

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for cardiac surgery

You may qualify if:

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

You may not qualify if:

• Patients with contraindications for placement of a central venous catheter will be excluded from this study.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (1)