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

NCT04456179 | Completed FDA Device

• 1 other identifier: PR2020-363
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• 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): 1. Hand grip 2. Weight lifting 3. Leg static effort

  3-4 hours per subject

Secondary Outcomes (1)

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

  3-4 hours per subject

Interventions

GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor DEVICE

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

Arrow® arterial catheterization kit (Teleflex) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: At least 30% of the subjects will be female and at least 30% will be male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensifree Ltd.: lead

Study Sites (1)

Clinimark Lab

Louisville, Colorado, 80027, United States

Location

Study Officials

• Arthur Ruiz Cabrera, M.D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 2, 2020
• Study Start: February 3, 2020
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)