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

Not Applicable

Completed

• Conditions: Blood Pressure Measurement

• Registration Number: NCT04456179
• Lead Sponsor: Sensifree Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2020-02-03
• Primary Completion: 2020-02-06
• Study Completion: 2020-02-06
• Status Verified: 2020-06
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans	3-4 hours per subject	Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): 1. Hand grip; 2. Weight lifting; 3. Leg static effort

Secondary Outcome Measures

Name	Time	Method
Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device	3-4 hours per subject	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: 1. Hand grip; 2. Weight lifting; 3. Leg static effort

Trial Locations

Locations (1)

Clinimark Lab; 🇺🇸 Louisville, Colorado, United States