Trials / Terminated
TerminatedNCT03407287
Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status:
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 180 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intravenous waveform Analysis (PIVA) signal.
Detailed description
Intravascular volume status determination remains elusive. Standard vital sign monitoring, including heart rate and blood pressure, fails to detect intravascular volume depletion and volume overload. Likewise, invasive monitoring is fraught with risk including vascular injury and central line associated infections. As such, a minimally-invasive mechanism to overcome the barriers of standard monitoring to detect volume status derangement, would be highly valuable. The goal of the study is to perform a series of observational feasibility studies in healthy and hospitalized subjects to determine effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the PIVA signal
Conditions
- Systemic Inflammatory Response Syndrome
- Distributive Shock
- Hypotension and Shock
- Decompensated Congestive Heart Failure
- Atrial Fibrillation
- High Risk Non-cardiac Surgery
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Peripheral Intravenous Analysis (PIVA) | Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV |
| PROCEDURE | Standard of care invasive vascular monitoring | Standard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status. |
| PROCEDURE | Standard noninvasive vascular monitoring | Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate. |
Timeline
- Start date
- 2018-01-08
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2018-01-23
- Last updated
- 2021-04-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03407287. Inclusion in this directory is not an endorsement.