Correlation Research Study: IQ2, NcIQ and IQ101
Condition: Heart Failure; Dyspnea; Hypertension; Pacemaker; Trauma
MeSH terms: Dyspnea
Study type: Interventional
Phase: Phase 1

Summary: 
      The new NcIQ thoracic impedance monitor is based on the predicate device, the IQ101. The new
      model uses the same 3-dimensional signal averaging as the original device, but also include
      second radio frequency signal to permit the device to work "wirelessly", i.e., without
      electrode lead attachments to the patient. This study seeks to 1) validate the use of the new
      device and confirm the correlation of the IQ101 and NcIQ. 2) Evaluate the ease of the new
      device.

      The new IQ2 thoracic impedance monitor is based on the predicate device, the IQ101. The new
      model uses the same 3-dimensional signal averaging as the original device, but with smaller
      housing and updated operating software. This study seeks to 1) Validate the use of the new
      device and confirm the correlation of the IQ101 and IQ2. 2) Compare the ease of the devices.
    

Detailed description: 
      The IQ101 is the first generation of the non invasive cardiograph. This device uses impedance
      to a micro-electric field passing from the electrodes. The NcIQ uses Radio frequencies and
      the same 3 dimensional signal averaging algorithm used in the IQ101 to generate hemodynamic
      data. The radio waves enables the device to work without the contact lead arrays used in the
      IQ2 and can take measurements without even contacting the patient, hence can be applied
      through clothing and is simple to apply. This makes the potential use by first responders a
      possibility. The device measures the change in the radio wave reflection during the cardiac
      cycle to estimate ardiac function. Specifically, it measures cardiac output, the amount of
      blood pumped per minute, and other hemodynamic parameters previously only measurable with
      invasive catheters. The data us used to generate a LIFESCORE and can measure and report
      dangerous trends to the caretaker. The device has a companion device to download the data for
      the hospital providers to create a seamless transfer of care. The new device uses technology
      similar to the previous generation machine but has been miniaturized, given updated operating
      system, and newer computer technology that helped make the device smaller, and faster. The
      underlying patented algorithm was not changed. Therefore, it is expected to provide the same
      degree of accuracy and precision as the predicate device.

      The IQ101 is the first generation of the non invasive cardiograph. This device uses impedance
      to a micro-electric field passing from the electrodes. The device can use the impedance and
      the change in the impedance during the cardiac cycle to estimate thoracic fluid volumes and
      cardiac function. Specifically, it measures cardiac output, the amount of blood pumped per
      minute, and other hemodynamic parameters previously only measurable with invasive catheters.
      There are many studies documenting the device's performance. The new device uses the same
      technology but has been modernized with updated operating system, and newer computer
      technology that helped make the device smaller, and faster. The device has also been
      redesigned to make operator use simpler and reduce the number wires involved. The underlying
      patented algorithm was not changed. Therefore, it is expected to provide the same degree of
      accuracy and precision as the predicate device with simplified user interface and lighter,
      smaller, more portable housing to improve ease of use.
    

Intervention name(s): Noninvasive Hemodynamic Patient Monitor
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Noninvasive; Hemodynamic; Monitoring; Critical Care; Swan-Ganz