ClearSight Validation in Pediatrics
Condition: Shock; Hypotension and Shock
MeSH terms: Hypotension; Shock
Study type: Observational

Summary: 
      Specific aim 1: The specific aim of this study is to compare cardiac output measurements as
      well as cardiac index, and stroke volume obtained via thermodilution during a cardiac
      catheterization with data obtained by the ClearSight cardiac output monitoring system.
      Specific aim 2: To compare arterial blood pressure measurements obtained by arterial line
      with arterial waveform measurements obtained by the ClearSight System. The hypothesis is:
      Cardiac output measurements or arterial blood pressure measurements taken non-invasively with
      the ClearSight system in pediatric patients who are either undergoing cardiac catheterization
      or have an arterial line will correlate with cardiac output measurements taken by pulmonary
      artery catheter thermodilution or arterial pressures measured by an arterial line.
    

Detailed description: 
      Specific aim number one: To compare cardiac output measurements obtained from the Clear Sight
      cardiac output monitor with measurements obtained with thermodilution in the cardiac
      catheterization laboratory. Significance: Currently, based on the Surviving Sepsis
      guidelines, fluid administration is supposed to be guided by measurements of fluid
      responsiveness. Currently, there are very few ways to obtain measurements of fluid
      responsiveness, such as cardiac output, stroke volume, and systemic vascular resistance
      non-invasively. The invasive methods are no longer used in pediatrics, as the risk of placing
      these invasive catheters is felt to outweigh the benefit of using the data provided by the
      invasive cardiac output monitoring systems. Although the Clear Sight cardiac output
      monitoring system has been validated in adults to measure cardiac output non-invasively, this
      technology has not been evaluated in pediatrics. If the Clear Sight monitoring system is
      shown to be accurate in pediatrics, it would safely provide data that could be lifesaving to
      a pediatric patient in shock.

      Specific aim number two: To compare the accuracy of the Clear Sight cardiac output monitor in
      obtaining continuous blood pressure measurements non-invasively. Significance: Currently, the
      only reliable method to continuously monitor blood pressure in critically ill patients is
      with an invasive intra-arterial catheter. Placing this catheter carries risks with it,
      including risk of infection as well as risk of intra-arterial thrombus which can lead to limb
      ischemia. The Clear Sight cardiac output monitor has the technology to obtain continuous
      blood pressure measurements non-invasively, although this technology has never been validated
      in pediatric patients. Therefore, specific aim 1 is to determine if this technology can
      reliably be used in pediatric patients. If it can, this would provide a method to obtain
      continuous blood pressure measurements without the risk of an invasive catheter.

      Hypothesis: Cardiac output and arterial blood pressure measurements taken non-invasively with
      the ClearSight system in will correlate with cardiac output measurements taken by pulmonary
      artery catheter thermodilution and arterial blood pressure measurements taken by arterial
      line. This hypothesis is based on personal communications with the developers of this device.
    

Intervention name(s): Measurement by Clearsight device
Intervention type(s): Device
Intervention description(s): Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients admitted to the ICU requiring an arterial line, or patients undergoing
        cardiac output measurements by cardiac catheterization by thermodilution.