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OpenTrials
Completed

NCT Number: NCT04510753

Data Collection of Arterial Line Waveform and BP Values

Collect continuous systolic and diastolic blood pressure values and waveforms as recorded by an arterial line catheter and by non-invasive blood pressure (NIBP) and to collect Photoplethysmogram Pulse Oximetry (PPG) waveform in order to optimize the Sensifree algorithm.

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Key information

Conditions

Blood Pressure Measurement

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

About this study

Sensifree is developing a continuous non-invasive blood pressure measurement system, that uses a fingertip PPG sensor as a signal source. The system provides systolic, diastolic and mean arterial pressure values, for use in hospitals and other clinical settings. The PPG waveform is analyzed by a proprietary software algorithm, calculating BP values.

The current best method to obtain similar information is by using an Arterial line catheter which will serve as a reference device. In this study, the sponsor aims to prospectively collect continuous radial arterial line & PPG waveforms, as well as NIBP data over the period of the surgery in order to test and refine the algorithm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed inform consent
  • Age 18 or greater
  • Elective surgery that requires invasive BP monitoring (A-line)

Exclusion criteria

  • Emergency surgery
  • A-line not inserted
  • Informed consent not signed

Treatment and study plan

Arterial catheterization kit

Device

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

GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor

Device

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

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.

Primary outcomes

  1. Comparison of BP values between a PPG sensor based device and an arterial line

    Time frame: The length of each procedure, typically up to 8 hours

    PPG signal will be acquired from the PPG sensor, while blood pressure values (systolic, diastolic, mean) will be acquired from A-line. PPG signal will be analyzed by the Sensifree's algorithm and compared to the A-line BP measurement results according to ISO 81060-2 accuracy specifications

Sponsors and collaborators

Lead sponsor

Sensifree Ltd.

Industry

Registry information

Official study title

Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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