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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT00883922
Collaborator
(none)
70
Enrollment
1
Location
36
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 1, 2007
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 12 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 UCLA Los Angeles California United States 90095

      Sponsors and Collaborators

      • University of California, Los Angeles

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Aman Mahajan, Principal Investigator, University of California, Los Angeles
      ClinicalTrials.gov Identifier:
      NCT00883922
      Other Study ID Numbers:
      • 06-12-078-03
      First Posted:
      Apr 20, 2009
      Last Update Posted:
      Jun 12, 2018
      Last Verified:
      Jun 1, 2018
      Additional relevant MeSH terms:
      Heart Defects, Congenital

      Study Results

      No Results Posted as of Jun 12, 2018