Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
This study is not yet open for participant recruitment.
Verified December 2012 by University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Kevin Kuo, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01760044
First received: December 28, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
We are conducting research about oxygen levels in the body and whether we can 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). We would like to know how this device compares to standard measurements using blood from a catheter. This may help us treat patients who may not be getting enough oxygen to their body.
| Condition | Intervention |
|---|---|
|
Tissue Oxygenation and Perfusion Status |
Device: Tissue oxygenation monitoring |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients |
Further study details as provided by 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 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: Buccal mucosa R-StO2 monitoring using the Pendar Medical Raman Oximeter
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760044
Contacts
| Contact: Kevin Kuo, M.D. | (734) 764-5302 | kkevin@med.umich.edu |
Locations
| United States, Michigan | |
| C.S. Mott Children's Hospital | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan
More Information
No publications provided
| Responsible Party: | Kevin Kuo, Fellow, Pediatric Critical Care, University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT01760044 History of Changes |
| Other Study ID Numbers: | NATP001 |
| Study First Received: | December 28, 2012 |
| Last Updated: | December 28, 2012 |
| Health Authority: | United States: University of Michigan Health Systems Internal Review Board |
Keywords provided by University of Michigan:
|
tissue oxygenation perfusion status |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013