Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

Sepsis Clinical Trial

Official title:

Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760044
• Other study ID #: NATP001
• Status: Completed
• Phase: N/A
• First received: December 28, 2012
• Last updated: May 19, 2017
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Shock

Intervention

Device:
• Tissue oxygenation monitoring
The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tissue oxygenation level as measured by raman spectroscopy device	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.	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	Microcirculation as recorded by sublingual video microcirculation recorder.	Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.	Twice in the first 24 hours after PICU admission
Secondary	Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)	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.	Continuous from PICU admission through 24 hours of admission