Blood Pressure MeasurementNCT04510753
Data Collection of Arterial Line Waveform and BP Values
An observational study of Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- Arterial catheterization kit, GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor and NIBP Cuff (GE Healthcare)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 9 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
Who may be able to join
- Signed inform consent
- Age 18 or greater
- Elective surgery that requires invasive BP monitoring (A-line)
Who cannot join
- Emergency surgery
- A-line not inserted
- Informed consent not signed
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
About this study
Official title: Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line
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.
Read the detailed description
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
- Blood Pressure Measurement
- Being tested
- Arterial catheterization kit, GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor, NIBP Cuff (GE Healthcare)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial catheterization kitDevice
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 SensorDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The length of each procedure, typically up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start22 Nov 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensifree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Wallace, MD, PhD, Principal investigator, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510753
- Sponsor's protocol ID
- CLN-30-0054
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line
- ClinicalTrials.gov ID
- NCT04510753
- Acronym / sponsor ID
- CLN-30-0054
- Conditions
- Blood Pressure Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sensifree Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
Key inclusion criteria (3 listed)
- Signed inform consent
- Age 18 or greater
- Elective surgery that requires invasive BP monitoring (A-line)
Key exclusion criteria (3 listed)
- Emergency surgery
- A-line not inserted
- Informed consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial catheterization kitInvasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values. | Device | – |
| GE Datex-Ohmeda Finger Clip Pulse Oximeter SensorPPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform | 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. | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure Measurement
Not yet recruiting
Equivalence of Systolic Blood Pressure Measurements Between Fowler and Seated Positions
Blood Pressure Measurement
Recruiting
The Effect of Web-Based Simulation and Flipped Learning on Blood Pressure Education
Education, Education Nursing
Not yet recruiting
Effects of Smartphone Use and Television Viewing on Standardized BP Measurement: The SCREENS-BP Study
Hypertension
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
RecruitingObservational study
Measurement Agreement Between IBP and NIBP During Induction of Anesthesia in High Risk Patients
Blood Pressure Monitoring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Wallace, MD, PhD principal investigator
San Francisco Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.