Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-03 @ 8:54 AM
Study NCT ID:
NCT04324593
Status:
TERMINATED
Last Update Posted:
2021-04-01
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA
Sponsor:
Baxter Healthcare Corporation
Organization:
Study Overview
Official Title:
Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by Peripheral Intravenous Analysis (PIVA) Technology
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Pro00041143 | OTHER | Advarra | View |