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

Stopped early · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04324593

Run by

Baxter Healthcare Corporation

People needed

26

Starts

2020-02-26

Expected to finish

2020-03-21

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Baxter Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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