Correlation Research Study: IQ2, NcIQ and IQ101 (NMT-CT)

This study has been completed.
Sponsor:
Collaborators:
University of Florida
Shand's Medical Center
Information provided by:
Noninvasive Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00491777
First received: June 22, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Heart Failure
Dyspnea
Hypertension
Pacemaker
Trauma
Device: Noninvasive Hemodynamic Patient Monitor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlation Study of NMT's IQ2, NcIQ and Its' Predicate Technology, IQ101.

Resource links provided by NLM:


Further study details as provided by Noninvasive Medical Technologies, Inc.:

Primary Outcome Measures:
  • A direct correlation between output parameters of IQ2/NcIQ to IQ101

Enrollment: 25
Study Start Date: June 2007
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age – 18-80 years
  • Weight – 80-300 pounds
  • Height – 5.0 feet – 6feet 4 inches Exclusion Criteria
  • Ongoing medical emergency or acute medical illness
  • NcIQ or ECG electrode adhesive allergy or sensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491777

Sponsors and Collaborators
Noninvasive Medical Technologies, Inc.
University of Florida
Shand's Medical Center
Investigators
Study Chair: Kevin Ferguson, MD Shand's Hospital
Principal Investigator: Joseph A Tyndall, MD Shand's Hospital
Study Director: David Seaberg, MD Shand's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00491777     History of Changes
Other Study ID Numbers: NMT-IQ2/NcIQ
Study First Received: June 22, 2007
Last Updated: June 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Noninvasive Medical Technologies, Inc.:
Noninvasive
Hemodynamic
Monitoring
Critical Care
Swan-Ganz

Additional relevant MeSH terms:
Dyspnea
Heart Failure
Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014