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

NCT ID: NCT04456179

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2020-02-06

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

Blood Pressure Measurement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

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

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

Intervention Type: DEVICE

Arrow® arterial catheterization kit (Teleflex)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sensifree Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Ruiz Cabrera, M.D

Role: PRINCIPAL_INVESTIGATOR

Locations

Clinimark Lab

Louisville, Colorado, United States

Countries

United States

Other Identifiers

PR2020-363

Identifier Type: -

Identifier Source: org_study_id