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Completed

NCT Number: NCT01760044

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

30 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue oxygenation monitoring

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2013
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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