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 Overview

• Status: Completed
• Conditions: Sepsis; Shock
• Intervention / Treatment: Device: Tissue oxygenation monitoring

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 Names: R-StO2 (Raman Tissue Oxygenation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Kevin Ward, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: tissue oxygenation; perfusion status
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NATP001