Data Collection of Arterial Line Waveform and BP Values

NCT04510753 | Completed FDA Device

• 1 other identifier: CLN-30-0054
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

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

  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

  The length of each procedure, typically up to 8 hours

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• Age 18 or greater
• Elective surgery that requires invasive BP monitoring (A-line)

You may not qualify if:

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

Sponsors & Collaborators

• Sensifree Ltd.: lead

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Study Officials

• Arthur Wallace, MD, PhD

  San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 12, 2020
• Study Start: November 22, 2019
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: June 7, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)