NCT01760044

Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 30 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Shock

Interventions

Type	Name	Description
DEVICE	Tissue oxygenation monitoring	The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-01-03
• Last updated: 2017-05-23

Locations

1 site across 1 country: United States