Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies

NCT04100668 | Completed FDA Device

• 1 other identifier: PR2017-240
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter. The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• Comparison of signals acquired from the investigational device, pulse oximeter, and arterial line

  BP waveform will be acquired form three sources (PPG, A-line and investigational device),data will be statistically analyzed to find the correlations between the different sources of BP waveform

  Three hours

Secondary Outcomes (1)

• Evaluation of waveform signal changes with different arm positions

  Three hours

Study Arms (1)

Data collection

EXPERIMENTAL

Comparing radial arterial line, Sensifree's Alpha sensor and PPG sensor pressure waveforms

Device: Sensifree's Alpha sensor; Device: Arrow® arterial catheterization kit (Teleflex); Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor

Interventions

Sensifree's Alpha sensor DEVICE

RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform

Data collection

Arrow® arterial catheterization kit (Teleflex) DEVICE

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

Data collection

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

Data collection

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General:
• 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
• Screening and Phase 1:
• Subject is from 20 to 55 years old.
• Subject has wrist circumference size within 145 and 220mm for both arms.
• Subjects with lateral blood pressure difference (auscultatory cuff based measurement) is less than: 15 mmHg for systolic blood pressure. 10 mmHg for diastolic blood pressure.
• Subjects with investigational device signal quality higher than a predefined value
• Subjects with similar investigational devices signals between their two arms.
• Phase 2 (all requirements as Phase 1 except):
• Subject is from 20 to 85 years old.
• At least 60% of subjects will have hypertensive blood pressure values (goal) (systolic \>140 mmHg and/or diastolic \>90 mmHg)
• At least 15% of subjects will have hypotensive blood pressure values (goal) (systolic \<110 mmHg and/or diastolic \<60 mmHg).
• No more than 25% of subjects will have normotensive blood pressure values (goal) (systolic from 110 to 140 mmHg and/or diastolic from 60 to 90 mmHg).

You may not qualify if:

• Subject with a BMI over 39
• Deformities or abnormalities that may prevent proper application of the device under test
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• 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

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: September 24, 2019
• Study Start: September 26, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)