Clinical trial NCT04324593: Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA
Official title: Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by Peripheral Intravenous Analysis (PIVA) Technology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Signal Quality Index (SQI) Score by Supine, Sitting, Standing Body Positions
timeFrame: End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
Secondary outcomes:
measure: Agreement between PIVA algorithm-derived RR and RR measured with Capnography at Baseline
timeFrame: End of 10 minute baseline
measure: Agreement between PIVA algorithm-derived RR and RR measured with Nellcor bedside monitor at Baseline
timeFrame: End of 10 minute baseline
measure: Agreement between PIVA algorithm-derived RR and RR measured with manual counting
timeFrame: End of 10 minute baseline
measure: Agreement between PIVA algorithm derived PR and PR measured with Nellcor bedside monitor at Baseline
timeFrame: End of 10 minute baseline
measure: Change in PIVA algorithm derived volume index between supine and passive leg raising positions
timeFrame: End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
measure: Change in PIVA algorithm derived volume index between supine and standing positions
timeFrame: End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baxter Investigational Site
state: Florida
Study officials:
References: