This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Kuo, University of Michigan
ClinicalTrials.gov Identifier:
NCT01760044
First received: December 28, 2012
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Sepsis Shock Device: Tissue oxygenation monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Official Title: Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

Further study details as provided by Kevin Kuo, University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: January 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760044

Locations
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Kevin Ward, MD University of Michigan
  More Information

Responsible Party: Kevin Kuo, Fellow, Pediatric Critical Care, University of Michigan
ClinicalTrials.gov Identifier: NCT01760044     History of Changes
Other Study ID Numbers: NATP001
Study First Received: December 28, 2012
Last Updated: May 19, 2017

Keywords provided by Kevin Kuo, University of Michigan:
tissue oxygenation
perfusion status

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 26, 2017