Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- tissue oxygenation level as measured by raman spectroscopy device
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 30 Days to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tissue oxygenation monitoring
Tissue oxygenation monitoring
Intervention: Tissue oxygenation monitoring (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)
Investigators
Kevin Kuo
Fellow, Pediatric Critical Care
University of Michigan