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

NCT ID: NCT00883922

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Aman Mahajan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

06-12-078-03

Identifier Type: -

Identifier Source: org_study_id