Data Collection of Arterial Line Waveform and BP Values

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-22

Study Completion Date

2020-12-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Blood Pressure Measurement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Arterial catheterization kit

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

Intervention Type DEVICE

GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor

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

Intervention Type DEVICE

NIBP Cuff (GE Healthcare)

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.

Intervention Type DEVICE