Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
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.
|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|
- 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.
- 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.
|Study Start Date:||January 2013|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760044
|United States, Michigan|
|C.S. Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Kevin Ward, MD||University of Michigan|