Noninvasive Cardiac MonitoringNCT01434771
Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
An observational study of Noninvasive Cardiac Monitoring, run by University of Florida.
Trial summary
The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Cardiac Monitoring
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for open heart surgery
Who may be able to join
- 18 years and older
- Weight - 36-136 Kilograms
- Height - 1.52 meters - 1.92 meters (5'- 6'4")
- Scheduled for open heart surgery during the study period
Who cannot join
- ECG lead adhesive allergy or sensitivity
- Pregnant Patients
- Prisoners
- Cognitively impaired
- Patients requiring mechanical cardiac support, or requirement for hemodialysis
- Patients not requiring pulmonary artery catheters for medical management.
- Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography
About this study
Official title: Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.
- Conditions
- Noninvasive Cardiac Monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Sponsor never funded study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive Cardiac MonitoringStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Noninvasive Medical Technologies, Inc., United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kevin L Ferguson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434771
- Sponsor's protocol ID
- 20110031
- Status last verified
- Oct 2013
- First submitted
- 13 Sep 2011
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
- ClinicalTrials.gov ID
- NCT01434771
- Acronym / sponsor ID
- 20110031
- Conditions
- Noninvasive Cardiac Monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor never funded study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Noninvasive Medical Technologies, Inc., United States Department of Defense
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for open heart surgery
Key inclusion criteria (4 listed)
- 18 years and older
- Weight - 36-136 Kilograms
- Height - 1.52 meters - 1.92 meters (5'- 6'4")
- Scheduled for open heart surgery during the study period
Key exclusion criteria (7 listed)
- ECG lead adhesive allergy or sensitivity
- Pregnant Patients
- Prisoners
- Cognitively impaired
- Patients requiring mechanical cardiac support, or requirement for hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L Ferguson, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Noninvasive Cardiac Monitoring, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.