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

Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by Peripheral Intravenous Analysis (PIVA) Technology

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 Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Peripheral intravenous analysis (PIVA) algorithm

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Baxter Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
  • previous heart attack
  • blocked artery
  • unexplained shortness of breath
  • congestive heart failure
  • history of stroke
  • transient ischemic attack
  • carotid artery disease
  • myocardial ischemia
  • myocardial infarction
  • restrictive or constrictive cardiomyopathy
  • congenital heart disease other than patent foramen ovale, repaired atrial or ventricular septal defect
  • any type of cardiac valve disease
  • history of cardiac arrhythmias

• Self-reported health conditions as identified in the Health Assessment Form

  • diabetes
  • uncontrolled thyroid disease
  • kidney disease / chronic renal impairment
  • history of seizures (except childhood febrile seizures)
  • epilepsy
  • history of unexplained syncope
  • history of migraine attacks in the last 3 months
  • head injury within the last 2 months
  • cancer / chemotherapy
  • other known health condition should be considered upon disclosure in health assessment form
  • history of substance abuse or addiction to alcohol and or drugs within the last 12 months

• Subjects with self-reported bleeding disorders including but not limited to:

  • hemophilia
  • von Willebrand disease
  • history of blood clots
  • history of bleeding problems
  • bruises easily with everyday activities
• Subjects taking prescription blood thinners (like aspirin, clopidogrel, dipyridamole, or ticlopidine).
• Subjects may be excluded at the discretion of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IV line with an attached Deltran BP transducer; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): March 21, 2020
• Study Completion (Actual): March 21, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BXU544319; Pro00041143 (Other Identifier: Advarra)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No