Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA

NCT04324593 | Terminated FDA Device

• 2 other identifiers: BXU544319Pro00041143
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)

Secondary Outcomes (6)

• Agreement between PIVA algorithm-derived RR and RR measured with Capnography at Baseline

  End of 10 minute baseline

• Agreement between PIVA algorithm-derived RR and RR measured with Nellcor bedside monitor at Baseline

  End of 10 minute baseline

• Agreement between PIVA algorithm-derived RR and RR measured with manual counting

  End of 10 minute baseline

• Agreement between PIVA algorithm derived PR and PR measured with Nellcor bedside monitor at Baseline

  End of 10 minute baseline

• Change in PIVA algorithm derived volume index between supine and passive leg raising positions

  End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)

Study Arms (1)

IV line with an attached Deltran BP transducer

EXPERIMENTAL

After device setup, subjects will be guided through a series of manipulations of the IV set while waveforms, pulse rate (PR), respiratory rate (RR) are collected at the start and stop of each test. At the end of the study, the PIVA algorithm will then be applied to the waveforms and calculated values will be compared with those from bedside monitors to understand the effect of common manipulations on the waveforms and determine most optimal conditions for capturing RR and PR through peripheral IV analysis.

Device: Peripheral intravenous analysis (PIVA) algorithm

Interventions

Peripheral intravenous analysis (PIVA) algorithm DEVICE

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.

IV line with an attached Deltran BP transducer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has reviewed, understood and signed an informed consent.
• Age between 18-55 years.
• Body mass index between 18.5-35 kg/m2 with a minimum weight of 45 kg.
• Willing and able to comply with study procedures and duration.
• Subjects wearing any type of nail polish and/or acrylic nails must be willing to remove them prior to admission.

You may not qualify if:

• Female subjects who are pregnant.
• Subjects who are currently participating in, or have within the past 30 days participated in, another interventional clinical study or have used an investigational device or drug within the past 30 days.
• Subjects with known respiratory conditions including but not limited to:
• uncontrolled / severe asthma
• flu / influenza
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• respiratory or lung surgery
• emphysema, chronic obstructive pulmonary disease, lung disease
• any other health condition that the Principal Investigator thinks can affect respiratory health
• Subjects with self-reported heart or cardiovascular conditions including but not limited to:
• hypertension
• history of cardiovascular surgery
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Baxter Investigational Site

Miami, Florida, 33126, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: February 26, 2020
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)