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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883922
• Other study ID #: 06-12-078-03
• Status: Completed
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: June 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Congenital Heart Defects
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States,