Correlation Research Study: IQ2, NcIQ and IQ101

NCT00491777 | Completed Phase 1 DMC

• 1 other identifier: NMT-IQ2/NcIQ
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Dyspnea; Hypertension; Pacemaker; Trauma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• A direct correlation between output parameters of IQ2/NcIQ to IQ101

Interventions

Noninvasive Hemodynamic Patient Monitor DEVICE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Noninvasive Medical Technologies, Inc.: lead
• University of Florida: collaborator
• Shand's Medical Center: collaborator

MeSH Terms

Conditions

Heart Failure; Dyspnea; Hypertension; Wounds and Injuries

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Kevin Ferguson, MD

  Shand's Hospital

  STUDY CHAIR

• Joseph A Tyndall, MD

  Shand's Hospital

  PRINCIPAL INVESTIGATOR

• David Seaberg, MD

  Shand's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 26, 2007

Record last verified: 2007-06