Clinical trial NCT01760044: Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Official title: Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Shock
Keywords: tissue oxygenation
perfusion status
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: tissue oxygenation level as measured by raman spectroscopy device
timeFrame: 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.
Secondary outcomes:
measure: Microcirculation as recorded by sublingual video microcirculation recorder.
timeFrame: Twice in the first 24 hours after PICU admission
measure: Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
timeFrame: Continuous from PICU admission through 24 hours of admission
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kevin Ward, MD
role: PRINCIPAL_INVESTIGATOR
References: