Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

• ClinicalTrials.gov Identifier: NCT01760044
• Recruitment Status: Completed
• First Posted: January 3, 2013
• Last Update Posted: May 23, 2017
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Kevin Kuo, University of Michigan

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.

Condition or disease	Intervention/treatment	Phase
Sepsis; Shock	Device: Tissue oxygenation monitoring	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
• Study Start Date: January 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.

Eligibility Criteria

• 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

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
• Other Study ID Numbers: NATP001
• First Posted: January 3, 2013
• Last Update Posted: May 23, 2017
• Last Verified: May 2017

Keywords provided by Kevin Kuo, University of Michigan:

tissue oxygenation; perfusion status

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes