Correlation Research Study: IQ2, NcIQ and IQ101

NCT ID: NCT00491777

Last Updated: 2007-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-06-30

Brief 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.

Conditions

Heart Failure; Dyspnea; Hypertension; Pacemaker; Trauma

Keywords

Noninvasive; Hemodynamic; Monitoring; Critical Care; Swan-Ganz

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Noninvasive Hemodynamic Patient Monitor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age - 18-80 years
• Weight - 80-300 pounds

Exclusion Criteria

• Ongoing medical emergency or acute medical illness
• NcIQ or ECG electrode adhesive allergy or sensitivity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Shand's Medical Center

UNKNOWN

Sponsor Role: collaborator

Noninvasive Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Kevin Ferguson, MD

Role: STUDY_CHAIR

Shand's Hospital

Joseph A Tyndall, MD

Role: PRINCIPAL_INVESTIGATOR

Shand's Hospital

David Seaberg, MD

Role: STUDY_DIRECTOR

Shand's Hospital

Other Identifiers

NMT-IQ2/NcIQ

Identifier Type: -

Identifier Source: org_study_id