Back to resultsNoninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Primary Purpose
Sepsis, Shock
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tissue oxygenation monitoring
Sponsored by
About this trial
This is an interventional device feasibility trial for Sepsis focused on measuring tissue oxygenation, perfusion status
Eligibility 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
Sites / Locations
- C.S. Mott Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tissue oxygenation monitoring
Arm Description
Tissue oxygenation monitoring
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01760044
Brief Title
Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Official Title
Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Shock
Keywords
tissue oxygenation, perfusion status
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tissue oxygenation monitoring
Arm Type
Experimental
Arm Description
Tissue oxygenation monitoring
Intervention Type
Device
Intervention Name(s)
Tissue oxygenation monitoring
Other Intervention Name(s)
R-StO2 (Raman Tissue Oxygenation)
Intervention Description
The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.
Primary Outcome Measure Information:
Title
tissue oxygenation level as measured by raman spectroscopy device
Description
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.
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.
Secondary Outcome Measure Information:
Title
Microcirculation as recorded by sublingual video microcirculation recorder.
Description
Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.
Time Frame
Twice in the first 24 hours after PICU admission
Title
Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
Description
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.
Time Frame
Continuous from PICU admission through 24 hours of admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ward, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
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Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
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