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Clinical Trials/NCT01760044
NCT01760044
Completed
Not Applicable

Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

University of Michigan1 site in 1 country46 target enrollmentJanuary 2013
ConditionsSepsisShock

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
University of Michigan
Enrollment
46
Locations
1
Primary Endpoint
tissue oxygenation level as measured by raman spectroscopy device
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter. Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Kuo

Fellow, Pediatric Critical Care

University of Michigan

Eligibility 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

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Microcirculation as recorded by sublingual video microcirculation recorder.(Twice in the first 24 hours after PICU admission)
  • Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)(Continuous from PICU admission through 24 hours of admission)

Study Sites (1)

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