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

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ClinicalTrials.gov Identifier: NCT00883922
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Aman Mahajan, University of California, Los Angeles

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.


Condition or disease
Congenital Heart Defects Cardiac Surgery

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery
Actual Study Start Date : March 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883922


Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles

Responsible Party: Aman Mahajan, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00883922     History of Changes
Other Study ID Numbers: 06-12-078-03
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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