Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Kevin Kuo, University of Michigan
ClinicalTrials.gov Identifier:
NCT01760044
First received: December 28, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.


Condition Intervention
Tissue Oxygenation and Perfusion Status
Device: Tissue oxygenation monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • tissue oxygenation level as measured by raman spectroscopy device [ Time Frame: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU. ] [ Designated as safety issue: No ]
    Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.


Secondary Outcome Measures:
  • Microcirculation as recorded by sublingual video microcirculation recorder. [ Time Frame: Twice in the first 24 hours after PICU admission ] [ Designated as safety issue: No ]
    Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.

  • Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM) [ Time Frame: Continuous from PICU admission through 24 hours of admission ] [ Designated as safety issue: No ]
    Bioinformatically enabled armband monitor (BEAM) will be placed on the patient's upper extremity for the first 24 hours of their admission and will be subsequently removed. The data will be stored in the device and investigators and clinicians caring for subjects will be blinded to the device output as data is collected. The device continually captures physiologic data such as heart rate, ECG results, and temperature.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tissue oxygenation monitoring
Tissue oxygenation monitoring
Device: Tissue oxygenation monitoring
The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.
Other Name: R-StO2 (Raman Tissue Oxygenation)

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
  • Age >30 days and <18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava

Exclusion Criteria:

  • Age <30 days or >18 years
  • Known pregnancy or subsequently discovered pregnancy after admission
  • Uncorrected cyanotic congenital heart disease

Relative Exclusion Criteria:

  • Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
  • Upper extremity trauma preventing placement of BEAM device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760044

Contacts
Contact: Kevin Kuo, M.D. (734) 764-5302 kkevin@med.umich.edu

Locations
United States, Michigan
C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Kevin Ward, MD University of Michigan
  More Information

No publications provided

Responsible Party: Kevin Kuo, Fellow, Pediatric Critical Care, University of Michigan
ClinicalTrials.gov Identifier: NCT01760044     History of Changes
Other Study ID Numbers: NATP001
Study First Received: December 28, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
tissue oxygenation
perfusion status

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014