Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure

Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line

The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.

Study Overview

• Status: Completed
• Conditions: Blood Pressure Measurement
• Intervention / Treatment: Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor; Device: Arrow® arterial catheterization kit (Teleflex)

Detailed Description

On a first visit a screening procedure to verify inclusion / exclusion criteria are met will be conducted. On the primary procedure visit, data collection will begin with the subjects having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed on them for data collection and to monitor their safety for the duration of the study. A physician will place an arterial line in the radial artery. The Sensifree cNIBP system will be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken on the arm opposite the arterial line.

A series of blood pressure changes will be induced, including various combinations of methods.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must have the ability to understand and provide written informed consent
• Subject must be willing and able to comply with study procedures and duration

Exclusion Criteria:

• Subject with a BMI over 39
• Deformities or abnormalities that may prevent proper application of the device under test
• Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic
• Tachycardia or resting heart rate less than 45 bpm
• Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)

• Subjects with known respiratory conditions such as: (self-reported)

  • uncontrolled / severe asthma,
  • flu,
  • pneumonia / bronchitis,
  • shortness of breath / respiratory distress,
  • respiratory or lung surgery,
  • emphysema, COPD, lung disease

• Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)

  • have had cardiovascular surgery
  • have cardiac pacemakers and/or automatic internal cardio-defibrillator
  • Chest pain (angina)
  • Abnormal pulse pressure
  • previous heart attack
  • blocked artery
  • unexplained shortness of breath
  • congestive heart failure (CHF)
  • history of stroke
  • transient ischemic attack
  • carotid artery disease
  • myocardial ischemia
  • myocardial infarction
  • cardiomyopathy
  • Pulsus Paradoxus

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

  • diabetes,
  • uncontrolled thyroid disease,
  • kidney disease / chronic renal impairment,
  • history of seizures (except childhood febrile seizures),
  • epilepsy,
  • history of unexplained syncope,
  • recent history of frequent migraine headaches,
  • recent head injury
  • cancer / chemotherapy

• Subjects with known clotting disorders (self-reported)

  • history of bleeding disorders or personal history of prolonged bleeding from injury
  • history of blood clots
  • hemophilia
  • current use of blood thinner: prescription or daily use of aspirin
• Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
• Subjects with a contact allergy to ultrasound gel.
• Subjects with prior or known allergies to iodine or lidocaine (or similar pharmacological agents, e.g. Novocaine)
• Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test
• Subject is intoxicated during the time of the visit, or was intoxicated within 24 hours prior to study visit, as reported by the subject, or per study staff judgment.
• Other known health condition, should be considered upon disclosure in health assessment form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans	Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): Hand grip; Weight lifting; Leg static effort	3-4 hours per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device	Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure: Hand grip; Weight lifting; Leg static effort	3-4 hours per subject

Collaborators and Investigators

• Sponsor: Sensifree Ltd.
• Investigators: Principal Investigator: Arthur Ruiz Cabrera, M.D

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): February 6, 2020
• Study Completion (Actual): February 6, 2020

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PR2020-363

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