## Protocol Section
### Identification Module
**NCT ID:** NCT04456179

**Brief Title:** Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure

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

#### Organization Study ID Info
**ID:** PR2020-363
#### Organization
**Class:** INDUSTRY
**Full Name:** Sensifree Ltd.
### Status Module
#### Completion Date
**Date:** 2020-02-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-02

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-02-06

**Type:** ACTUAL

#### Start Date
**Date:** 2020-02-03

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-03
**Study First Submit QC Date:** 2020-06-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sensifree Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Blood Pressure Measurement

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform

**Name:** GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor

**Type:** DEVICE

#### Intervention 2

**Description:** Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform

**Name:** Arrow® arterial catheterization kit (Teleflex)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans

**Time Frame:** 3-4 hours per subject

#### Secondary Outcomes

**Description:** 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

**Measure:** Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device

**Time Frame:** 3-4 hours per subject

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** At least 30% of the subjects will be female and at least 30% will be male

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Louisville

**Country:** United States

**Facility:** Clinimark Lab

**State:** Colorado

**Zip:** 80027

#### Overall Officials

**Official 1:**

**Name:** Arthur Ruiz Cabrera, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
