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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
26
An IV line with an attached Deltran BP transducer will be used together with LabChart software to record venous waveforms during various interventions. These waveforms will be processed using the PIVA algorithm and the calculated values will be compared to those from Nellcor respiratory monitor, Capnograph and cardiac telemetry monitoring.
Baxter Investigational Site
Miami, Florida, United States
Signal Quality Index (SQI) Score by Supine, Sitting, Standing Body Positions
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.
Time frame: End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
Agreement between PIVA algorithm-derived RR and RR measured with Capnography at Baseline
The difference of the PIVA algorithm-derived outcomes to their comparators (Capnography) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum. The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints. Capnography is the monitoring of the concentration or partial pressure of carbon dioxide in the respiratory gases.
Time frame: End of 10 minute baseline
Agreement between PIVA algorithm-derived RR and RR measured with Nellcor bedside monitor at Baseline
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum. The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
Time frame: End of 10 minute baseline
Agreement between PIVA algorithm-derived RR and RR measured with manual counting
The manual count value will be an average of the 2 minutes then the count is taken over. The difference of the PIVA algorithm-derived outcomes to their comparators (manual) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum. The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
Time frame: End of 10 minute baseline
Agreement between PIVA algorithm derived PR and PR measured with Nellcor bedside monitor at Baseline
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum. The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
Time frame: End of 10 minute baseline
Change in PIVA algorithm derived volume index between supine and passive leg raising positions
The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
Time frame: End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
Change in PIVA algorithm derived volume index between supine and standing positions
The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
Time frame: End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
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