Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01760044|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Shock||Device: Tissue oxygenation monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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)
- 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.
- Microcirculation as recorded by sublingual video microcirculation recorder. [ Time Frame: Twice in the first 24 hours after PICU admission ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760044
|United States, Michigan|
|C.S. Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Kevin Ward, MD||University of Michigan|