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NCT04324593 · ClinicalTrials.gov registry record · NA
Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA
A NA study, sponsored by Baxter Healthcare Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT04324593: Clinical Trial NA study, sponsored by Baxter Healthcare Corporation.
NCT04324593 is a NA study that was terminated before completion, run by Baxter Healthcare Corporation. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04324593, a NA study, was terminated before completion, sponsored by Baxter Healthcare Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
Non-invasive sensors have been used in research in the United States (US) to aid in the assessment of a subject's heart rate (HR), respiratory rate (RR) and fluid volume status. This estimate and its trended value over time, when used along with clinical signs and symptoms and other subject test results, can aid in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of volume status, or RR are suspected. Non-invasive sensors like the Peripheral IntraVenous Analysis (PIVA) sensor under development by Baxter and the Deltran blood pressure (BP) transducer, capture waveforms created by physiological mechanisms such as blood flow and breathing. An algorithm is then applied to the captured waveform to give clinicians an idea of hemodynamic (volume) status, and RR. In this study, the functional robustness (e.g., subjects sitting, elevated leg positions, etc.) of the PIVA algorithm/technology will be demonstrated by evaluating the impact of various common interventions on the venous pressure signal. All subjects will undergo 33 interventions expected to take approximately 4 - 6 hours.
Primary Outcome
Ranking of subject body positions (supine, sitting, standing) based upon their impact on the venous waveform signal, from best to worst, based on the PIVA algorithm-derived SQI. Score on the scale include 0=no signal, 1=poor signal, 2=good signal. The highest percentage of time with good signal quality will be the best ranked position, and the lowest percentage of time with good signal quality will be the worst ranked position.
Interventions
- DEVICE Peripheral intravenous analysis (PIVA) algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2020-03-21 |
| Phase | NA |
Why NCT04324593 stopped before completion
NCT04324593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Peripheral intravenous analysis (PIVA) algorithm is the first listed.
NCT04324593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04324593 about?
NCT04324593 is a clinical study titled "Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA". Non-invasive sensors have been used in research in the United States (US) to aid in the assessment of a subject's heart rate (HR), respiratory rate (RR) and fluid volume status. This estimate and its trended value over time, when used along with clinical signs and symptoms and other subject test res...
What is the current status of trial NCT04324593?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2020-02-26. Estimated completion is 2020-03-21.
What interventions are being tested in trial NCT04324593?
The interventions under investigation include: Peripheral intravenous analysis (PIVA) algorithm (DEVICE).
Who is sponsoring clinical trial NCT04324593?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04324593's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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