NCT04132453

Completed

Continuous Blood Pressure and Waveform Measurements Comparis...

Sensifree Ltd.Source

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Other study identifiers

Sponsor study identifier

CLI-0003.04

Study Type

observational

Actual enrollment (reported)

100

Locations

1 country

Sites

1

Timeline

Study Start

June 19, 2018

Actual (reported)

Primary Completion

March 31, 2021

Actual (reported)

Study Completion

March 31, 2021

Actual (reported)

Brief Summary

The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 100 participants
Study completion date: March 31, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 19, 2018
Actual (reported)
First Submitted
October 16, 2019
Actual (reported)
First Posted
October 18, 2019
Actual (reported)
Primary Completion
March 31, 2021
Actual (reported)
Study Completion
March 31, 2021
Actual (reported)

Last Updated: June 9, 2022
Status Verified: October 2020
Last Update Submitted: June 6, 2022

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

Comparison of waveforms and BP values between PPG sensor and arterial line
Blood pressure waveform will be acquired from the PPG while blood pressure waveform and values (systolic, diastolic, mean) will be acquired from A-line. PPG data will be analyzed by the Sensifree's algorithm and compared to the A-line measurement results according to ISO 81060-2 accuracy specifications
3 months after last patient enrolled

Interventions

Arterial catheterization kitDevice

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

GE Datex-Ohmeda Finger Clip Pulse Oximeter SensorDevice

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

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring

You may qualify if:

Signed inform consent

Sponsors & Collaborators

Sensifree Ltd.
Industrylead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Study Officials

Inbal Dabush-Elisha, MD
Wolfson Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

June 19, 2018

Actual (reported)

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NIBP Cuff (GE Healthcare)

Device

A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Age 18-20

Elective surgery that requires invasive BP monitoring (A-line)

You may not qualify if:

Emergency surgery
Subject has a condition that might prevent BP fluctuations
Subject is taking medicine that might prevent BP fluctuations
Arterial line not placed in the radial artery
Flush test has inadequate frequency response pre-trial
Subject's arterial line contralateral hand is not available for PPG sensor placement
Subject has 50% or more pacemaker dependency

Contact the study team to confirm eligibility.

Primary Completion

March 31, 2021

Actual (reported)

Study Completion

March 31, 2021

Actual (reported)

Last Updated

June 9, 2022

Record last verified: 2020-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04132453
Data provider: ClinicalTrials.gov
Source updated: 2022-06-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:11 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations